The search for a vaccine against group B streptococci Group B streptococci are one of the leading causes of infection in newborn infants, causing pneumonia, septicaemia or meningitis. A group of Portuguese researchers and a team in a CNRS-associated laboratory at the Institut Pasteur have just identified a protein in this micro-organism which allows it to colonise a host by modulating its immune system. According to these scientists, who have published this study in the Journal of Immunology, the protein thus identified is a possible candidate for the development of a vaccine against Group B Streptococci.
Infections caused by group B streptococci (Streptococcus agalactiae) are an important public health problem. Some 800 cases of invasive infections in newborn infants are recorded each year in France; they mainly result from transmission from the mother to the infant. Mortality linked to these infections remains high (50 to 100 deaths each year), and despite antibiotic therapy, 25 to 50% of the infants who survive suffer from neurological after-effects.
A new prospect for the development of a vaccine against group B streptococci has just been discovered, thanks to a study carried out in the laboratory headed by Paula Ferreira, at the Institute for Biomedical Sciences - Abel Salazar - in Porto, working in collaboration with Patrick Trieu-Cuot, head of the CNRS-associated Unit for the Biology of Pathogenic Gram-positive Bacteria at the Institut Pasteur.
Some proteins produced by pathogenic micro-organisms are capable of interfering with the immune system of the host in order to facilitate microbial colonisation.
The scientists have shown that a protein secreted by group B streptococci, called GAPDH, was capable of raising the level of one of the "messengers" in the immune system, a cytokine called IL-10 (interleukin-10). Such an increase in IL-10 diminishes the immune defences, so that invasive bacterial infection is facilitated. The researchers also showed that IL-10-deficient mice were much more resistant to infection by group B streptococci.
The team thus concluded that GAPDH could be used to ensure immune protection against group B streptococci. Preliminary immunization studies in the mouse demonstrated a protective effect of GAPDH against group B streptococcal infection, thus confirming that this protein should be a good vaccine candidate.
"The ideal vaccination strategy would consist in inducing mucosal immunity, and thus eliminate the vaginal carriage of group B streptococci," explains Patrick Trieu-Cuot. "This vaccination would make it possible to eliminate the antibiotic prophylaxis given at the onset of labour to women who are infected by this micro-organism." It should be remembered that systematic screening is currently ensured between the 34th and 37th weeks of amenorrhoea.
The researchers are now working on the development of this vaccination strategy.
###
For further information about group B streptococcal infections, read the information document published by the Institut Pasteur: http://www.pasteur.fr/actu/presse/documentation/Strepto_A_B.htm#B
Source: "Streptococcus agalactiae GAPDH is a virulence-associated immunomodulatory protein": Journal of Immunology, February 1st, 2007.
Pedro Madureira1, Marina Baptista1, Marta Vieira1, Vanessa Magalhães1, Ana Camelo1, Liliana Oliveira1, Adìlia Ribeiro1,2, Delfina Tavares1,2, Patrick Trieu-Cuot3, Manuel Vilanova1,2 and Paula Ferreira1,2
1. ICBAS, Institute for Biomedical Sciences - Abel Salazar, Porto, Portugal
2. IBMC, Institute for Molecular and Cellular Biology, Porto, Portugal
3. Unit for the Biology of Pathogenic Gram-positive Bacteria, CNRS URA 2172, Institut Pasteur, Paris, France
Contact: Monica McCarthy
CNRS
Infectious diseases articles and news.Symptoms of infectious diseases, manifestations of the disease, diagnosis, medications and treatment.
February 28, 2007
New HIV/AIDS Cases In Japan Reach Record High In 2006, Government Report Says
The number of people newly diagnosed with HIV and those who developed AIDS in Japan in 2006 reached record highs of 914 and 390, respectively, according to preliminary data released Wednesday by the Japanese AIDS Surveillance Committee, the Kyodo/Yahoo! Asia News reports (Kyodo/Yahoo! Asia News, 2/7). According to the committee's report, the most significant increase in new HIV cases occurred among men who have sex with men, and 15 times more men than women reported a new HIV-positive diagnosis in 2006 (AFP/Nation, 2/8). In addition, an increasing number of people ages 30 and older became HIV-positive in 2006 compared with 2005, the report found. It also shows a nearly 10% increase in new HIV cases from 2005 to 2006 and a 6.3% increase for those who developed AIDS during the same time period, the AP/Forbes reports (AP/Forbes, 2/7). Revised data from 2005 indicate that 832 new HIV cases and 385 AIDS cases were reported that year (Kyodo/ Yahoo! Asia News, 2/7). In addition, the report found that the number of people in Japan receiving no-cost HIV tests increased by 16.2% in 2006, suggesting that HIV/AIDS awareness in the country is increasing, according to AFP/Nation (AFP/Nation, 2/8). "While the number of people getting checks is growing, we believe infections themselves are on the increase," Aikichi Iwamoto, committee chair and a professor at the University of Tokyo's Institute of Medical Science, said, adding, "Given most were infected through sexual contacts, we hope people will understand that HIV is increasingly common, take preventive measures and get examined early if they are worried about anything." This was the third consecutive year that HIV/AIDS cases in Japan totaled more than 1,000 and reached record highs, the Kyodo/Yahoo! Asia News reports (Kyodo/Yahoo! Asia News, 2/7).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Detecting Salmonella In 24 Hours
The food and drink we consume have to pass strict quality controls. Nevertheless, these measures are not always sufficient, given that sometimes certain foodstuffs can still give rise to food poisoning, most often caused by micro-organisms. The Salmonella bacterium is undoubtedly one of the best known of these. At the University of the Basque Country (UPV/EHU) they are developing a new, rapid-detection system (within 24 hours) for Salmonella.
It is currently a laborious process to detect Salmonella in food. An analytical study is carried out in the laboratory by means of conventional microbiological techniques and the results take a week, a delay which creates problems for the food industry
In 2002 the Department of Immunology, Microbiology and Parasitology at the UPV/EHU together with the company, Laboratorios BromatolГіgicos Araba, and the Leioa Technological Centre, decided to carry out collaborative work in order to try to develop new, faster methods for Salmonella detection.
Genetic methods
A requisite for such genetic methods is to know the genome of this bacterium well. Fortunately there are several strains of Salmonella which have been totally sequenced. It is also known that there are certain genes that are specific to Salmonella that are not found in any other bacteria nor, for that matter, in any other living being. Thus, if we detect these genes, it means the presence of Salmonella. Although we may not detect the entire micro-organism, we can find the DNA of this bacteria.
The study of this DNA has given rise to technical developments which enable the detection of the presence or absence of Salmonella within 24 hours in food. Nevertheless, these methods based on the detection of DNA have a drawback. DNA is a very stable molecule that enables its study in persons who have died many years before. The same can happen in bacteria, i.e. it may be that we are identifying the DNA but that the bacteria have been destroyed by pasteurisation or sterilisation. The researchers have shown that the detection of the DNA in itself is not sufficient to identify the Salmonella given that, using this technique, it is not possible to know if the bacterium is dead or alive.
So the UPV/EHU found another, more specific marker for the viability of the bacteria - messenger RNA; an unstable and easily degradable molecule which is only produced when the bacteria is in the multiplication phase (and thus capable of producing infection), and is subsequently destroyed. Armed with this knowledge, the UPV/EHU research team designed a procedure to extract this RNA from foodstuffs, with subsequent transformation of this RNA into DNA and the detection of the latter.
Working with RNA means working with great precision and speed, because it can give us false negative results, i.e. indicate that there is no salmonella when, in fact, there is, the molecule having degraded. The extraction procedure is a fundamental one: once the messenger RNA is extracted, it is transformed into DNA by means of inverse transcription; a process whereby a DNA copy is synthesised. This DNA copy is detected by certain probes previously developed by the research team. In fact, the probes are DNA chains that are complementary to Salmonella genes marked with a fluorescent compound. If the DNA copy and the complementary DNA unite, the fluorescent compound emits a signal detectable in real time. This device, moreover, enables the quantification of the reaction, i.e. it tells us the number of Salmonella cells present in the food sample.
What the UPV/EHU researchers are proposing, in fact, is a combination of techniques: extraction on the one hand; the design of probes for and detection of DNA and RNA molecules on the other. They are techniques complementary to the traditional cell cultures and that enable the analysis of more samples in less time, thus enhancing food safety globally.
###
Contact: Irati Kortabitarte
Elhuyar Fundazioa
It is currently a laborious process to detect Salmonella in food. An analytical study is carried out in the laboratory by means of conventional microbiological techniques and the results take a week, a delay which creates problems for the food industry
In 2002 the Department of Immunology, Microbiology and Parasitology at the UPV/EHU together with the company, Laboratorios BromatolГіgicos Araba, and the Leioa Technological Centre, decided to carry out collaborative work in order to try to develop new, faster methods for Salmonella detection.
Genetic methods
A requisite for such genetic methods is to know the genome of this bacterium well. Fortunately there are several strains of Salmonella which have been totally sequenced. It is also known that there are certain genes that are specific to Salmonella that are not found in any other bacteria nor, for that matter, in any other living being. Thus, if we detect these genes, it means the presence of Salmonella. Although we may not detect the entire micro-organism, we can find the DNA of this bacteria.
The study of this DNA has given rise to technical developments which enable the detection of the presence or absence of Salmonella within 24 hours in food. Nevertheless, these methods based on the detection of DNA have a drawback. DNA is a very stable molecule that enables its study in persons who have died many years before. The same can happen in bacteria, i.e. it may be that we are identifying the DNA but that the bacteria have been destroyed by pasteurisation or sterilisation. The researchers have shown that the detection of the DNA in itself is not sufficient to identify the Salmonella given that, using this technique, it is not possible to know if the bacterium is dead or alive.
So the UPV/EHU found another, more specific marker for the viability of the bacteria - messenger RNA; an unstable and easily degradable molecule which is only produced when the bacteria is in the multiplication phase (and thus capable of producing infection), and is subsequently destroyed. Armed with this knowledge, the UPV/EHU research team designed a procedure to extract this RNA from foodstuffs, with subsequent transformation of this RNA into DNA and the detection of the latter.
Working with RNA means working with great precision and speed, because it can give us false negative results, i.e. indicate that there is no salmonella when, in fact, there is, the molecule having degraded. The extraction procedure is a fundamental one: once the messenger RNA is extracted, it is transformed into DNA by means of inverse transcription; a process whereby a DNA copy is synthesised. This DNA copy is detected by certain probes previously developed by the research team. In fact, the probes are DNA chains that are complementary to Salmonella genes marked with a fluorescent compound. If the DNA copy and the complementary DNA unite, the fluorescent compound emits a signal detectable in real time. This device, moreover, enables the quantification of the reaction, i.e. it tells us the number of Salmonella cells present in the food sample.
What the UPV/EHU researchers are proposing, in fact, is a combination of techniques: extraction on the one hand; the design of probes for and detection of DNA and RNA molecules on the other. They are techniques complementary to the traditional cell cultures and that enable the analysis of more samples in less time, thus enhancing food safety globally.
###
Contact: Irati Kortabitarte
Elhuyar Fundazioa
Brazil To Install Condom Vending Machines In Schools As Part Of HIV Prevention Campaign
Brazil's Ministry of Health on Tuesday pledged to continue plans to install condom vending machines in schools nationwide as part of the country's HIV prevention efforts, Reuters/Washington Post reports. The health ministry recently launched a contest for technical schools to design an improved condom vending machine and will award the winning team with $25,000. Trial vending machines might be installed in schools as early as 2008, and the health ministry aims to install the machines in bars, clubs and 24-hour gas stations. In addition, a survey recently released by UNESCO found two-thirds of parents responded that they approve of the government offering teenagers increased access to no-cost condoms and sex education. The survey was conducted among 135 schools that participate in the condom distribution efforts, as well as a smaller number of nonparticipating schools, in about half of Brazil's states. It found that 45% of students ages 13 to 19 responded that they had active sex lives and that 60% to 70% reported using condoms to prevent sexually transmitted infections. About 10% of students said that they have had sex without a condom because they could not afford one, and 42% of students responded that they did not have a condom available (Reuters/Washington Post, 2/7).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
New Recommendations Against A Major Opportunistic Infection -- Cryptococcosis
CRNS and the Institut Pasteur conducted research in France on patients diagnosed with cryptococcosis which ranks second among fatal opportunistic infections in patients infected by HIV and who are profoundly immunosuppressed. A multicentric prospective study, published in PLoS Medicine, uncovers parameters associated with more severe infections, such as the patient's sex and the infecting serotype. In light of the results, the authors propose a modification in the therapeutic treatment of individuals suffering from cryptococcosis.
Caused by a microscopic fungus, Cryptococcus neoformans, cryptococcosis affects immunosuppressed individuals, most of whom are infected by HIV, but who also suffer from other immunological disorders or who are receiving immunosuppressive treatments. Most often, the fungus causes meningoencephalitis, but the infection can also be localised in the lungs. The incidence of cryptococcosis in France has decreased by half with the availability of antiretroviral combination therapies, and now represents around 100 cases annually. However, in Africa and Asia, it remains the second most fatal opportunistic infection after tuberculosis in individuals infected by HIV, in some countries affecting up to 30% of them in the absence of access to antiretroviral drugs. It is now the first cause of meningitis among adults in Africa.
A vast cohort study was performed on patients diagnosed with cryptococcosis between 1997 and 2001 in France by Françoise Dromer, head of the Molecular Mycology unit (CNRS URA 3012) and National Reference Centre for Mycoses and Antifungals at the Institut Pasteur, and Olivier Lortholary, from the same Pasteur unit and the Necker-Pasteur Infectiology Centre, in collaboration with the French Cryptococcosis Study Group, which is composed of mycologists and clinicians in 77 centres throughout the territory.
Aiming to analyse the factors influencing the clinical presentation of the disease and its evolution (prognostic factors), this study enrolled 230 patients infected (HIV+) or not (HIV-) by HIV.
It demonstrates that the disease is more severe in men than women, suggesting influence of sex hormones. It is also more severe in HIV+ than in HIV- individuals. In terms of mortality, it is those patients suffering from a haematological malignancy (such as lymphoma or chronic leukaemia) in which cryptococcosis is the most serious. The study also demonstrates that between the two serotypes of C. neoformans present in France (A and D), serotype A is associated with a more severe presentation and evolution of the disease. Finally, the patients having neurological defects and/or abnormal consciousness, or abnormal neuroimaging at the time of diagnosis, have a worsened prognosis for survival.
Along with these different factors, the researchers studied the impact of the initial "fungal load" (the quantity of fungi in the organism) and the evolution of cryptococcosis according to the particular antifungal drugs used.
In light of all of the factors analysed, the authors advocate that all patients in whom a diagnosis of cryptococcosis has been established should have an assessment of their fungal load to evaluate the severity of the disease.
According to the researchers, this systematic assessment should include a cerebrospinal fluid culture, a blood culture, a urine culture, and a determination of the quantity (titration) of the circulating antigen of Cryptococcus.
"For patients who have a very high fungal load, we recommend starting an initial therapy combining two antifungals, a treatment that is currently only recommended in cases of meningitis and severe pneumonia", concludes Dromer.
The authors stress that the three-month mortality rate from cryptococcosis remains 15-20% in Western countries, and that this is much higher in Africa and Asia: this greatly justifies improving the therapeutic management of this disease in the future.
###
To learn more about cryptococcosis, read the Institut Pasteur information sheet: http://www.pasteur.fr/actu/presse/documentation/mycoses.htm#crypto
Source:
"Determinants of disease presentation and outcome during cryptococcosis : the cryptoA/D study": PLoS Medicine, 6 February 2007.
Françoise Dromer1, Simone Mathoulin-Pélissier2, Odile Launay3, Olivier Lortholary1,4, the French Cryptococcosis Study Group
1. Molecular Mycology Unit, Mycology and Antifungals National Reference Centre, CNRS URA 3012, Institut Pasteur, Paris
2. Institut BergoniГ©, Regional Cancer Centre of the Southwest, Bordeaux
3. Faculty of Medicine, UniversitГ© Paris V, Cochin Hospital (Public Assistance-Paris Hospitals), Internal Medicine Department, Vaccinology Clinical Investigation Centre , Cochin-Pastuer, Paris
4. Faculty of Medicine, UniversitГ© Paris V - Necker-Enfants Malades Hospital, Infectious and Tropical Diseases Department, Necker Infectiology Centre (Public Assistance-Paris Hospitals) - Pasteur, Paris
Contact: Monica McCarthy
CNRS
Caused by a microscopic fungus, Cryptococcus neoformans, cryptococcosis affects immunosuppressed individuals, most of whom are infected by HIV, but who also suffer from other immunological disorders or who are receiving immunosuppressive treatments. Most often, the fungus causes meningoencephalitis, but the infection can also be localised in the lungs. The incidence of cryptococcosis in France has decreased by half with the availability of antiretroviral combination therapies, and now represents around 100 cases annually. However, in Africa and Asia, it remains the second most fatal opportunistic infection after tuberculosis in individuals infected by HIV, in some countries affecting up to 30% of them in the absence of access to antiretroviral drugs. It is now the first cause of meningitis among adults in Africa.
A vast cohort study was performed on patients diagnosed with cryptococcosis between 1997 and 2001 in France by Françoise Dromer, head of the Molecular Mycology unit (CNRS URA 3012) and National Reference Centre for Mycoses and Antifungals at the Institut Pasteur, and Olivier Lortholary, from the same Pasteur unit and the Necker-Pasteur Infectiology Centre, in collaboration with the French Cryptococcosis Study Group, which is composed of mycologists and clinicians in 77 centres throughout the territory.
Aiming to analyse the factors influencing the clinical presentation of the disease and its evolution (prognostic factors), this study enrolled 230 patients infected (HIV+) or not (HIV-) by HIV.
It demonstrates that the disease is more severe in men than women, suggesting influence of sex hormones. It is also more severe in HIV+ than in HIV- individuals. In terms of mortality, it is those patients suffering from a haematological malignancy (such as lymphoma or chronic leukaemia) in which cryptococcosis is the most serious. The study also demonstrates that between the two serotypes of C. neoformans present in France (A and D), serotype A is associated with a more severe presentation and evolution of the disease. Finally, the patients having neurological defects and/or abnormal consciousness, or abnormal neuroimaging at the time of diagnosis, have a worsened prognosis for survival.
Along with these different factors, the researchers studied the impact of the initial "fungal load" (the quantity of fungi in the organism) and the evolution of cryptococcosis according to the particular antifungal drugs used.
In light of all of the factors analysed, the authors advocate that all patients in whom a diagnosis of cryptococcosis has been established should have an assessment of their fungal load to evaluate the severity of the disease.
According to the researchers, this systematic assessment should include a cerebrospinal fluid culture, a blood culture, a urine culture, and a determination of the quantity (titration) of the circulating antigen of Cryptococcus.
"For patients who have a very high fungal load, we recommend starting an initial therapy combining two antifungals, a treatment that is currently only recommended in cases of meningitis and severe pneumonia", concludes Dromer.
The authors stress that the three-month mortality rate from cryptococcosis remains 15-20% in Western countries, and that this is much higher in Africa and Asia: this greatly justifies improving the therapeutic management of this disease in the future.
###
To learn more about cryptococcosis, read the Institut Pasteur information sheet: http://www.pasteur.fr/actu/presse/documentation/mycoses.htm#crypto
Source:
"Determinants of disease presentation and outcome during cryptococcosis : the cryptoA/D study": PLoS Medicine, 6 February 2007.
Françoise Dromer1, Simone Mathoulin-Pélissier2, Odile Launay3, Olivier Lortholary1,4, the French Cryptococcosis Study Group
1. Molecular Mycology Unit, Mycology and Antifungals National Reference Centre, CNRS URA 3012, Institut Pasteur, Paris
2. Institut BergoniГ©, Regional Cancer Centre of the Southwest, Bordeaux
3. Faculty of Medicine, UniversitГ© Paris V, Cochin Hospital (Public Assistance-Paris Hospitals), Internal Medicine Department, Vaccinology Clinical Investigation Centre , Cochin-Pastuer, Paris
4. Faculty of Medicine, UniversitГ© Paris V - Necker-Enfants Malades Hospital, Infectious and Tropical Diseases Department, Necker Infectiology Centre (Public Assistance-Paris Hospitals) - Pasteur, Paris
Contact: Monica McCarthy
CNRS
AHF Bans Pfizer Sales Representatives From Facilities In Response To Company's Promotion Of Erectile Dysfunction Drug
The AIDS Healthcare Foundation last week announced that it will ban Pfizer sales representatives from its facilities during business hours in response to how the drug maker markets its erectile dysfunction drug Viagra, the AP/Forbes reports (AP/Forbes, 2/8). AHF last month filed a lawsuit in Los Angeles Superior Court against Pfizer for allegedly promoting recreational use of Viagra in advertisements. AHF said Pfizer's ads for the drug have increased risky sexual behavior, as well as cases of HIV and other sexually transmitted infections, among men. The suit asks that Pfizer stop running ads that promote Viagra as a lifestyle drug and that the company fund ads promoting awareness about the risks associated with Viagra and STIs. In addition, the suit asks that Pfizer forfeit profits gained from the "misleading" ads and pay for AHF's costs of treating cases of HIV/AIDS and other STIs that it has linked to Viagra. AHF in December 2006 launched an ad campaign against Pfizer because it said the company's ads for Viagra promote recreational use. Pfizer at the time denied that the ads encourage recreational use of the drug and said that its advertising states that the drug does not protect against STIs (Kaiser Daily HIV/AIDS Report, 1/22).
Recent Actions
According to AHF, Pfizer representatives will not be allowed in its health care centers worldwide, including 14 centers in California and Florida (AHF release, 2/8). "After repeated attempts to engage Pfizer on the negative impact of its marketing and advertising strategy and tactics for ... Viagra, there has been no recognition by [Pfizer] of the documented correlation between Viagra and the recent rise in sexually transmitted diseases and HIV in men who have sex with men," AHF in the release said. The group added that Pfizer has "made no attempt to address this alarming trend." Pfizer in a statement said that AHF's decision is "unfortunate" because the "reality is Pfizer sales representatives provide very valuable and important information about medical conditions and Pfizer medicines designed to treat these conditions." The company added, "As a result, we believe this decision may negatively impact patients receiving care at local AHF clinics" (AP/Forbes, 2/8). In related news, an FDA advisory panel announced last week that it will meet on April 24 to examine the safety and efficacy of Pfizer's CCR5 blocker maraviroc, the AP/365Gay.com reports. Pfizer plans to offer the drug, which is taken twice daily, with a test developed by Monogram Biosciences that determines if people likely will respond to the treatment (AP/365Gay.com, 2/8).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Global Survey Of The Consequences Of Small And Large DNA Variants In Our Genome
Findings published in Science will accelerate the search for genes involved in human disease. The report provides a first genome-wide view of how the unique composition of genetic variation within each of us leads to unique patterns of gene activity.
By defining those genetic variants with a biological effect, the results will help prioritise regions of the genome that are investigated for association with disease. This is an important step to understanding links between genes and disease for individuals, and across populations.
The Human Genome Project gave us the instruction manual for building a human. The HapMap and Copy Number Variation (CNV) Projects developed indices of where to find differences in the manuals of different people. One of the challenges for research into variation and disease is that most variants have no consequence for our wellbeing.
The new study gives a global view of the consequences of those differences for gene activity. The work shows that activity of more than 1000 genes is affected by sequence variation and is the first map of human populations that identifies the most important fraction of DNA variation, that which directly affects gene activity.
The research was led by scientists from the Wellcome Trust Sanger Institute, together with colleagues from the University of Cambridge, Hospital for Sick Children/University of Toronto and Harvard Medical School/Brigham and Women's Hospital.
Using the HapMap series of cell samples from four populations, they measured the activity of more than 14,000 genes in cells grown in culture. The cell samples provide a snapshot of genetic activity in one cell type. The activity of each gene was then correlated with genetic variation nearby, as defined by the HapMap, an index of single-base changes (single nucleotide polymorphisms, or SNPs) and the new index of copy number variants (CNVs).
"We've been able to look back into our history and find changes that are older and likely to be shared among populations," explained Dr Manolis Dermitzakis, senior author and Project Leader at the Wellcome Trust Sanger Institute. "But we also find many that are newer and less widespread.
"These are part of our recent evolution and a step along the way to understanding the origin and personal consequences of genetic change, not least for our wellbeing. This is a first generation map of biologically important DNA sequence variation"
The understanding of the genetic basis of gene activity will help medical research to provide individuals with information about their personal predisposition to disease.
The study was a massive undertaking: it included HapMap genotype data on 700,000 SNPs located close to genes, as well as 25,000 sites interrogated for potential structural variation to examine copy-number differences, looking at the activity of 14,000 genes in 210 unrelated individuals.
SNP and CNV variation correlated with altered activity in almost 900 and 240 genes, respectively. The HapMap has been invaluable in detecting variants involved in many diseases and these results suggest that the CNV index will prove similarly useful.
"The remarkable finding was that there is such little overlap in the genes found by using the two indices," commented Dr Matthew Hurles, also a leader of the project at the Wellcome Trust Sanger Institute. "Only about 10% of the activity variants associated with a CNV were also associated with a SNP.
"This suggests that we must include CNV studies in our searches for genetic variation associated with disease or we will be missing a lot of the important genetic effects."
The results show that at least 10-20% of heritable variation in gene activity is due to CNVs. The team found associations that included previously known examples, such as UGT2B17, which has been associated with prostate cancer, proving that the new approach works well.
They also showed for the first time that activity of other genes, located close to UGT2B17, was affected. Finding other effects in this way will enhance the search for critical genes within a region of genetic possibilities.
Some associations were not found in all four populations, two-thirds (CNVs or SNPs) being found in only one population. A gene implicated in Spinal Muscular Atrophy showed an association in three populations, but not in Yoruba from Ibadan, Nigeria. Understanding population differences can help us understand our history.
Variation in copy number can affect gene activity by altering the 'dose' of a gene, by disrupting the active parts of a gene that contain the code for protein, or by disrupting the regulatory regions of the genome that control gene activity - the on/off and dimmer switches in our genome.
"Although the simplest model for a CNV affecting gene activity is where the variant is a deletion of a gene or part of a gene, we found examples where activity is affected from a distance," commented Barbara Stranger, first author and post-doctoral fellow at the Wellcome Trust Sanger Institute. "This may occur when the CNV reduces the effectiveness of a region that works to switch the genes on or off."
The survey gives the first global view of the effects of SNPs and CNVs on gene activity. The methods and resources developed will help researchers better understand the link between differences - large and small - in our genome and our health.
###
Publication details: Stranger BE et al. (2007) Relative impact of nucleotide and copy number variation on gene expression phenotypes. Science
Matthew Hurles and Manolis Dermitzakis are corresponding authors.
Funding
Funding was provided by the Wellcome Trust, the National Institutes of Health, Cancer Research UK, the Leukemia and Lymphoma Society and the Brigham and Women's Hospital Department of Pathology, the UK Medical Research Council, the Royal Society and Genome Canada/Ontario Genomics Institute.
Participating Centres
* Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, Cambridge, UK
* Department of Oncology, University of Cambridge, Cancer Research UK Cambridge Research Institute, Li Ka Shing Centre, Robinson Way, Cambridge, UK
* Istituto di Tecnologie Biomediche-Sezione di Bari, Consiglio Nazionale della Ricerche (CNR), Bari, Italy
* Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
* Broad Institute of Harvard and Massachusetts Institute of Technology, Cambridge, MA, USA
* The Centre for Applied Genomics and Program in Genetics and Genomic Biology, The Hospital for Sick Children, MaRS Centre, Toronto, Ontario, Canada
* Department of Molecular and Medical Genetics, University of Toronto, Toronto, Ontario, Canada
* Program in Molecular and Computational Biology, University of Southern California, Los Angeles, CA, USA.
Selected websites
GENEVAR - GENe Expression VARiation database
Copy Number Variation Project
Dr Dermitzakis' research
Dr Hurles' research
The Wellcome Trust Sanger Institute, which receives the majority of its funding from the Wellcome Trust, was founded in 1992 as the focus for UK sequencing efforts. The Institute is responsible for the completion of the sequence of approximately one-third of the human genome as well as genomes of model organisms such as mouse and zebrafish, and more than 90 pathogen genomes. In October 2006, new funding was awarded by the Wellcome Trust to enable the Institute to build on its world-class scientific achievements and exploit the wealth of genome data now available to answer important questions about health and disease. These programmes are built around a Faculty of more than 30 senior researchers. The Wellcome Trust Sanger Institute is based in Hinxton, Cambridge, UK. http://www.sanger.ac.uk/
The Wellcome Trust is the largest independent charity in the UK and the second largest medical research charity in the world. It funds innovative biomedical research, in the UK and internationally, spending around ВЈ500 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing.
Contact: Don Powell
Wellcome Trust Sanger Institute
By defining those genetic variants with a biological effect, the results will help prioritise regions of the genome that are investigated for association with disease. This is an important step to understanding links between genes and disease for individuals, and across populations.
The Human Genome Project gave us the instruction manual for building a human. The HapMap and Copy Number Variation (CNV) Projects developed indices of where to find differences in the manuals of different people. One of the challenges for research into variation and disease is that most variants have no consequence for our wellbeing.
The new study gives a global view of the consequences of those differences for gene activity. The work shows that activity of more than 1000 genes is affected by sequence variation and is the first map of human populations that identifies the most important fraction of DNA variation, that which directly affects gene activity.
The research was led by scientists from the Wellcome Trust Sanger Institute, together with colleagues from the University of Cambridge, Hospital for Sick Children/University of Toronto and Harvard Medical School/Brigham and Women's Hospital.
Using the HapMap series of cell samples from four populations, they measured the activity of more than 14,000 genes in cells grown in culture. The cell samples provide a snapshot of genetic activity in one cell type. The activity of each gene was then correlated with genetic variation nearby, as defined by the HapMap, an index of single-base changes (single nucleotide polymorphisms, or SNPs) and the new index of copy number variants (CNVs).
"We've been able to look back into our history and find changes that are older and likely to be shared among populations," explained Dr Manolis Dermitzakis, senior author and Project Leader at the Wellcome Trust Sanger Institute. "But we also find many that are newer and less widespread.
"These are part of our recent evolution and a step along the way to understanding the origin and personal consequences of genetic change, not least for our wellbeing. This is a first generation map of biologically important DNA sequence variation"
The understanding of the genetic basis of gene activity will help medical research to provide individuals with information about their personal predisposition to disease.
The study was a massive undertaking: it included HapMap genotype data on 700,000 SNPs located close to genes, as well as 25,000 sites interrogated for potential structural variation to examine copy-number differences, looking at the activity of 14,000 genes in 210 unrelated individuals.
SNP and CNV variation correlated with altered activity in almost 900 and 240 genes, respectively. The HapMap has been invaluable in detecting variants involved in many diseases and these results suggest that the CNV index will prove similarly useful.
"The remarkable finding was that there is such little overlap in the genes found by using the two indices," commented Dr Matthew Hurles, also a leader of the project at the Wellcome Trust Sanger Institute. "Only about 10% of the activity variants associated with a CNV were also associated with a SNP.
"This suggests that we must include CNV studies in our searches for genetic variation associated with disease or we will be missing a lot of the important genetic effects."
The results show that at least 10-20% of heritable variation in gene activity is due to CNVs. The team found associations that included previously known examples, such as UGT2B17, which has been associated with prostate cancer, proving that the new approach works well.
They also showed for the first time that activity of other genes, located close to UGT2B17, was affected. Finding other effects in this way will enhance the search for critical genes within a region of genetic possibilities.
Some associations were not found in all four populations, two-thirds (CNVs or SNPs) being found in only one population. A gene implicated in Spinal Muscular Atrophy showed an association in three populations, but not in Yoruba from Ibadan, Nigeria. Understanding population differences can help us understand our history.
Variation in copy number can affect gene activity by altering the 'dose' of a gene, by disrupting the active parts of a gene that contain the code for protein, or by disrupting the regulatory regions of the genome that control gene activity - the on/off and dimmer switches in our genome.
"Although the simplest model for a CNV affecting gene activity is where the variant is a deletion of a gene or part of a gene, we found examples where activity is affected from a distance," commented Barbara Stranger, first author and post-doctoral fellow at the Wellcome Trust Sanger Institute. "This may occur when the CNV reduces the effectiveness of a region that works to switch the genes on or off."
The survey gives the first global view of the effects of SNPs and CNVs on gene activity. The methods and resources developed will help researchers better understand the link between differences - large and small - in our genome and our health.
###
Publication details: Stranger BE et al. (2007) Relative impact of nucleotide and copy number variation on gene expression phenotypes. Science
Matthew Hurles and Manolis Dermitzakis are corresponding authors.
Funding
Funding was provided by the Wellcome Trust, the National Institutes of Health, Cancer Research UK, the Leukemia and Lymphoma Society and the Brigham and Women's Hospital Department of Pathology, the UK Medical Research Council, the Royal Society and Genome Canada/Ontario Genomics Institute.
Participating Centres
* Wellcome Trust Sanger Institute, Wellcome Trust Genome Campus, Hinxton, Cambridge, UK
* Department of Oncology, University of Cambridge, Cancer Research UK Cambridge Research Institute, Li Ka Shing Centre, Robinson Way, Cambridge, UK
* Istituto di Tecnologie Biomediche-Sezione di Bari, Consiglio Nazionale della Ricerche (CNR), Bari, Italy
* Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA
* Broad Institute of Harvard and Massachusetts Institute of Technology, Cambridge, MA, USA
* The Centre for Applied Genomics and Program in Genetics and Genomic Biology, The Hospital for Sick Children, MaRS Centre, Toronto, Ontario, Canada
* Department of Molecular and Medical Genetics, University of Toronto, Toronto, Ontario, Canada
* Program in Molecular and Computational Biology, University of Southern California, Los Angeles, CA, USA.
Selected websites
GENEVAR - GENe Expression VARiation database
Copy Number Variation Project
Dr Dermitzakis' research
Dr Hurles' research
The Wellcome Trust Sanger Institute, which receives the majority of its funding from the Wellcome Trust, was founded in 1992 as the focus for UK sequencing efforts. The Institute is responsible for the completion of the sequence of approximately one-third of the human genome as well as genomes of model organisms such as mouse and zebrafish, and more than 90 pathogen genomes. In October 2006, new funding was awarded by the Wellcome Trust to enable the Institute to build on its world-class scientific achievements and exploit the wealth of genome data now available to answer important questions about health and disease. These programmes are built around a Faculty of more than 30 senior researchers. The Wellcome Trust Sanger Institute is based in Hinxton, Cambridge, UK. http://www.sanger.ac.uk/
The Wellcome Trust is the largest independent charity in the UK and the second largest medical research charity in the world. It funds innovative biomedical research, in the UK and internationally, spending around ВЈ500 million each year to support the brightest scientists with the best ideas. The Wellcome Trust supports public debate about biomedical research and its impact on health and wellbeing.
Contact: Don Powell
Wellcome Trust Sanger Institute
Arkansas Bill Would Require Inmates To Receive HIV Test Before Being Paroled
Arkansas Rep. Fred Allen (R) on Thursday introduced a bill (HB 1444) in the state House that would require inmates in the state's prisons to undergo tests for HIV and other sexually transmitted infections before being paroled, the AP/Today's THV reports. The bill also would require that inmates receive treatment if they test positive for HIV or other STIs. According to Dina Tyler, spokesperson for the Arkansas Department of Correction, about 100 of the state's 14,000 inmates are HIV-positive, and 25 to 30 have progressed to AIDS. The state requires that inmates be tested for hepatitis when entering the prison system, but HIV tests are voluntary. Tyler said prison officials are examining the bill to determine what the additional testing would cost (AP/Today's THV, 2/8).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Groups Call On G8 To Deliver On 2005 Promises Made For African Development, Including Universal Access To HIV/AIDS Treatment
Some HIV/AIDS advocacy groups last week called on finance ministers from the Group of Seven industrialized nations, meeting on Friday in Germany, to fulfill commitments made by the Group of Eight industrialized nations at its 2005 summit regarding aid to Africa, including HIV/AIDS funding, South Africa's Star reports (Pienaar, Star, 2/9). G8 leaders in July 2005 at the close of their summit in Gleneagles, Scotland, agreed to an immediate doubling of aid to Africa to $50 billion annually in order to fight poverty and disease on the continent. The final summit communique officially endorsed a debt relief plan, which canceled at least $40 billion in debt owed by the world's 18 poorest nations. The communique also included an agreement on providing universal access to HIV/AIDS treatment, according to British Prime Minister Tony Blair (Kaiser Daily HIV/AIDS Report, 1/29). According to a report from ActionAid International, Germany, Italy, Japan and the U.S. have made no attempts to meet the target of universal access to antiretrovirals by 2010, London's Guardian reports. G8 countries still need to establish a funding plan to meet the treatment access goal, the report says, adding that although 1.6 million HIV-positive people worldwide have access to antiretrovirals, 5.2 million still need access (Elliott, Guardian, 2/8). Oxfam in a statement released Thursday called on G8 nations to deliver on promises made in Gleneagles, adding that significant funding increases are needed to meet the U.N. Millennium Development Goals by 2015. According to Oxfam, development aid decreased by 2.1% in 2005. "The G8 has a choice," Max Lawson of Oxfam said, adding, "Will 2007 be yet another year of broken promises to Africa or the year they finally put their words into action?" He added, "Germany has got to take the lead on this" (Star, 2/9). According to Aditi Sharma, international HIV/AIDS coordinator of ActionAid India, G8 nations should allocate $8 billion in 2007 and $10 billion annually thereafter to achieve the goal of universal access to treatment by 2010 (De Capua, VOA News, 2/8). Germany, which this year heads the G8, has agreed to put Africa on the agenda for this year's summit in Heiligendamm, Germany (Guardian, 2/8).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Yale Biologists 'trick' Viruses Into Extinction
While human changes to the environment cause conservation biologists to worry about species extinction, Yale biologists are reversing the logic by trying to trap viruses in habitats that force their extinction, according to a report in Ecology Letters.
To avoid going extinct a population must not only survive, but also reproduce. Paul Turner, associate professor of ecology and evolutionary biology at Yale, tested the practicality of luring a virus population into the wrong cells within the human body, thus preventing virus reproduction and alleviating disease.
"Ecological traps for viruses might arise naturally, or could be engineered by adding viral binding sites to cells that disallow virus reproduction," said senior author Turner. "We proved the concept using a non-human virus, and variants of the bacteria cells it infects."
In ecology, a habitat that supports population growth is termed a "source," whereas a non-supportive habitat is a "sink." This study reported on the success of phi-6 virus populations in environments containing different mixtures of ordinary "source" bacteria and mutant trap cells that act as "sinks."
Their research showed that when the number of trap cells exceeded a key threshold in the mixtures, the virus population could no longer sustain itself and declined toward extinction.
"This approach has intriguing potential for new treatments against human viruses," said Turner. "A similar idea already exists in agriculture, where farmers use non-harvested 'trap crops' to lure insect pests. Because the pests prefer the taste of the trap crops, only these plants need to be sprayed, reducing the amount of pesticide use."
Turner believes that similar trickery might be used against human viruses like HIV. He notes that HIV recognizes the T-cells it infects by CD4 molecules on the cell surface, but it then requires functions of the cell nucleus to reproduce. Current anti-HIV therapies are designed to maintain high T-cell counts in the human body, so that the immune system can properly function. But, these drugs therapies are very expensive.
Turner suggests, "A cheaper option is the possibility of engineering trap cells that have CD4 molecules on their surface, but no nucleus for virus reproduction. Mature red blood cells could fill the bill, because they lack a nucleus and could be engineered as sink habitats that greatly outnumber the T-cell source habitats in the body."
###
Co-authors on the paper are John J. Dennehy and Yul W. Yang who worked with Turner at Yale, and Nicholas A. Friedenberg at Dartmouth. The research was supported by the Woodrow Wilson Foundation and the National Science Foundation.
Citation: Ecology Letters, Published online: 2-Feb-2007 doi: 10.1111/j.1461-0248.2006.01013.x
Contact: Janet Rettig Emanuel
Yale University
To avoid going extinct a population must not only survive, but also reproduce. Paul Turner, associate professor of ecology and evolutionary biology at Yale, tested the practicality of luring a virus population into the wrong cells within the human body, thus preventing virus reproduction and alleviating disease.
"Ecological traps for viruses might arise naturally, or could be engineered by adding viral binding sites to cells that disallow virus reproduction," said senior author Turner. "We proved the concept using a non-human virus, and variants of the bacteria cells it infects."
In ecology, a habitat that supports population growth is termed a "source," whereas a non-supportive habitat is a "sink." This study reported on the success of phi-6 virus populations in environments containing different mixtures of ordinary "source" bacteria and mutant trap cells that act as "sinks."
Their research showed that when the number of trap cells exceeded a key threshold in the mixtures, the virus population could no longer sustain itself and declined toward extinction.
"This approach has intriguing potential for new treatments against human viruses," said Turner. "A similar idea already exists in agriculture, where farmers use non-harvested 'trap crops' to lure insect pests. Because the pests prefer the taste of the trap crops, only these plants need to be sprayed, reducing the amount of pesticide use."
Turner believes that similar trickery might be used against human viruses like HIV. He notes that HIV recognizes the T-cells it infects by CD4 molecules on the cell surface, but it then requires functions of the cell nucleus to reproduce. Current anti-HIV therapies are designed to maintain high T-cell counts in the human body, so that the immune system can properly function. But, these drugs therapies are very expensive.
Turner suggests, "A cheaper option is the possibility of engineering trap cells that have CD4 molecules on their surface, but no nucleus for virus reproduction. Mature red blood cells could fill the bill, because they lack a nucleus and could be engineered as sink habitats that greatly outnumber the T-cell source habitats in the body."
###
Co-authors on the paper are John J. Dennehy and Yul W. Yang who worked with Turner at Yale, and Nicholas A. Friedenberg at Dartmouth. The research was supported by the Woodrow Wilson Foundation and the National Science Foundation.
Citation: Ecology Letters, Published online: 2-Feb-2007 doi: 10.1111/j.1461-0248.2006.01013.x
Contact: Janet Rettig Emanuel
Yale University
Are Some People Immune To Avian Flu?
New results from Richard Webby at St. Jude Children's Research Hospital and colleagues published in the international open-access medical journal PLoS Medicine suggest that the answer might be yes.
The H5N1 avian flu virus is quite different from the seasonal H1N1 and H3N2 flu viruses most humans have been exposed to, which is why many scientists believe that H5N1 could start a new pandemic. (The H and N refer to two virus components, the proteins hemagglutinin and neuraminidase, each of which exists in several varieties identified by a number following the letter.)
Webby and colleagues wondered whether immunity to the human type 1 neuraminidase (huN1) in H1N1 influenza virus strains (and vaccines made to protect against them) could provide protection against avian H5N1 influenza virus, which contains the closely related avian type 1 neuraminidase (avN1). In the new study, they investigated this possibility in mice and in a small group of humans.
The researchers immunized mice with DNA that caused their cells to make the neuraminidase from an H1N1 virus found in human outbreaks. They then examined the immune response of the mice to this huN1 and to avN1 from an avian H5N1 virus isolated from a human patient (A/Vietnam/1203/04). Most of the mice responded to the DNA vaccine by making antibodies that recognized huN1; a few also made antibodies against avN1. (Antibodies are proteins circulating in the body that recognize and stick to some specific part of a foreign agent such as a virus.) All the vaccinated mice survived infection with a man-made flu virus containing huN1, and half also survived infection with low doses of A/Vietnam/1203/04 or of a man-made virus containing avN1.
The researchers then tested blood samples from 38 human volunteers for their ability to inactivate neuraminidase from an H1N1 virus and two H5N1 viruses. Most of the samples were active against the protein from the H1N1 virus; and 8 or 9 also inhibited the protein from both H5N1 viruses.
The results indicate that a vaccine containing huN1 makes mice produce antibodies that partly protect them against avian H5N1 infection. In addition, the human data suggest that a proportion of people have low titer antibodies against H5N1 influenza because of prior exposure to H1N1 viruses or routine influenza vaccination.
As Laura Gillim-Ross and Kanta Subbarao (US National Institute of Allergy and Infectious Diseases) write in an accompanying Perspective article, these results provide a tantalizing suggestion but fall short of demonstrating that there is actual protection in humans against avian flu. Further work is needed to investigate this important question, and Gillim-Ross and Subbarao discuss the challenges and opportunities for such research.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Both articles will also be part of a collection of articles published in PLoS Medicine and other PLoS journals on various aspects of influenza biology and control. The collection are live at http://collections.plos.org/plosmedicine/influenza-2007.php
Citation: Sandbulte MR, Jimenez GS, Boon ACM, Smith LR, Treanor JJ, et al. (2007) Cross-reactive neuraminidase antibodies afford partial protection against H5N1 in mice and are present in unexposed humans. PLoS Med 4(2): e59.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
St. Jude Public Relations
Related PLoS Medicine Perspective article:
Citation: Gillim-Ross L, Subbarao K (2007) Can immunity induced by the human infl uenza virus N1 neuraminidase provide some protection from avian infl uenza H5N1 viruses? PLoS Med 4(2): e91.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
Contact: Andrew Hyde
Public Library of Science
The H5N1 avian flu virus is quite different from the seasonal H1N1 and H3N2 flu viruses most humans have been exposed to, which is why many scientists believe that H5N1 could start a new pandemic. (The H and N refer to two virus components, the proteins hemagglutinin and neuraminidase, each of which exists in several varieties identified by a number following the letter.)
Webby and colleagues wondered whether immunity to the human type 1 neuraminidase (huN1) in H1N1 influenza virus strains (and vaccines made to protect against them) could provide protection against avian H5N1 influenza virus, which contains the closely related avian type 1 neuraminidase (avN1). In the new study, they investigated this possibility in mice and in a small group of humans.
The researchers immunized mice with DNA that caused their cells to make the neuraminidase from an H1N1 virus found in human outbreaks. They then examined the immune response of the mice to this huN1 and to avN1 from an avian H5N1 virus isolated from a human patient (A/Vietnam/1203/04). Most of the mice responded to the DNA vaccine by making antibodies that recognized huN1; a few also made antibodies against avN1. (Antibodies are proteins circulating in the body that recognize and stick to some specific part of a foreign agent such as a virus.) All the vaccinated mice survived infection with a man-made flu virus containing huN1, and half also survived infection with low doses of A/Vietnam/1203/04 or of a man-made virus containing avN1.
The researchers then tested blood samples from 38 human volunteers for their ability to inactivate neuraminidase from an H1N1 virus and two H5N1 viruses. Most of the samples were active against the protein from the H1N1 virus; and 8 or 9 also inhibited the protein from both H5N1 viruses.
The results indicate that a vaccine containing huN1 makes mice produce antibodies that partly protect them against avian H5N1 infection. In addition, the human data suggest that a proportion of people have low titer antibodies against H5N1 influenza because of prior exposure to H1N1 viruses or routine influenza vaccination.
As Laura Gillim-Ross and Kanta Subbarao (US National Institute of Allergy and Infectious Diseases) write in an accompanying Perspective article, these results provide a tantalizing suggestion but fall short of demonstrating that there is actual protection in humans against avian flu. Further work is needed to investigate this important question, and Gillim-Ross and Subbarao discuss the challenges and opportunities for such research.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Both articles will also be part of a collection of articles published in PLoS Medicine and other PLoS journals on various aspects of influenza biology and control. The collection are live at http://collections.plos.org/plosmedicine/influenza-2007.php
Citation: Sandbulte MR, Jimenez GS, Boon ACM, Smith LR, Treanor JJ, et al. (2007) Cross-reactive neuraminidase antibodies afford partial protection against H5N1 in mice and are present in unexposed humans. PLoS Med 4(2): e59.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
St. Jude Public Relations
Related PLoS Medicine Perspective article:
Citation: Gillim-Ross L, Subbarao K (2007) Can immunity induced by the human infl uenza virus N1 neuraminidase provide some protection from avian infl uenza H5N1 viruses? PLoS Med 4(2): e91.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
Contact: Andrew Hyde
Public Library of Science
High Rates Of Latent TB Infection Found In Russian Health Workers
Testing for tuberculosis has revealed that nearly 40% of the doctors in one Russian city have latent infection, with even higher levels in those who work in TB clinics. The research has been published in PLoS Medicine.
TB disease is a growing problem worldwide. Russia is one country where it is particularly common. Although up to a third of the world's population are infected with the bacterium that causes the disease, in most people the infection remains 'latent'. It is important to detect latent infection in order to reduce the spread of the infection and to hold back the rise in the number of active cases. Working in Samara City in the Russian Federation, researchers from Queen Mary College, UK and colleagues in Samara, tested both health workers and students for latent TB. All the health staff, including students, were found to have higher rates of infection than other people in Samara. The 47% infection rate found in staff in TB clinics was ten times higher than that in the population at large.
The study authors say that, although more research is first needed, it may be necessary to conduct regular occupational health screening for latent infection followed by treatment where appropriate. However, even this may not be effective in controlling rates of active infection, as resistance to TB drugs is so common.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Note: The test used by the researchers was not the 'traditional' tuberculin skin test, as this is not reliable when used with people who were given the 'BCG' vaccination for TB early in life, which is common in Russia as in many other countries. The new 'IFN-gamma' test gave good results and the researchers recommend that it be used in further research of this kind.
Citation: Drobniewski F, Balabanova Y, Zakamova E, Nikolayevskyy V, Fedorin I (2007) Rates of latent tuberculosis in health care staff in Russia. PLoS Med 4(2): e55.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Francis Drobniewski
Barts and the London School of Medicine and Dentistry
Queen Mary College
University of London
2 Newark Street
London, E1 2AT United Kingdom
Contact: Andrew Hyde
Public Library of Science
TB disease is a growing problem worldwide. Russia is one country where it is particularly common. Although up to a third of the world's population are infected with the bacterium that causes the disease, in most people the infection remains 'latent'. It is important to detect latent infection in order to reduce the spread of the infection and to hold back the rise in the number of active cases. Working in Samara City in the Russian Federation, researchers from Queen Mary College, UK and colleagues in Samara, tested both health workers and students for latent TB. All the health staff, including students, were found to have higher rates of infection than other people in Samara. The 47% infection rate found in staff in TB clinics was ten times higher than that in the population at large.
The study authors say that, although more research is first needed, it may be necessary to conduct regular occupational health screening for latent infection followed by treatment where appropriate. However, even this may not be effective in controlling rates of active infection, as resistance to TB drugs is so common.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Note: The test used by the researchers was not the 'traditional' tuberculin skin test, as this is not reliable when used with people who were given the 'BCG' vaccination for TB early in life, which is common in Russia as in many other countries. The new 'IFN-gamma' test gave good results and the researchers recommend that it be used in further research of this kind.
Citation: Drobniewski F, Balabanova Y, Zakamova E, Nikolayevskyy V, Fedorin I (2007) Rates of latent tuberculosis in health care staff in Russia. PLoS Med 4(2): e55.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Francis Drobniewski
Barts and the London School of Medicine and Dentistry
Queen Mary College
University of London
2 Newark Street
London, E1 2AT United Kingdom
Contact: Andrew Hyde
Public Library of Science
Ethiopians With TB Must Overcome Barriers To Complete Treatment
One in five Ethiopians treated for tuberculosis fails to complete the length course of drugs required, according to a study by Ethiopian and Norwegian researchers, published in PLoS Medicine. The research has made clear some of the difficulties that patients must overcome in order to succeed in completing a course of treatment. People who cannot easily travel to a treatment centre are the most likely to 'default'.
Tuberculosis is one of the world's leading causes of death and the number of cases is increasing. Ethiopia is one of the worst affected countries. The treatment recommended by the World Health Organization (WHO) can be very effective for most patients but it does involve taking drugs for at least six months. Patients may find it difficult to complete the full treatment, although it helps to have a system where trained observers help make sure that each patient takes all the necessary pills. WHO promotes this approach - known as DOTS (directly observed treatment short course) - and says national programs should aim for a treatment completion rate of at least 85%. Ethiopia was already known to have made good progress towards this goal during the 1990s. However, the researchers wanted to know why those people still not completing treatment were failing to do so.
They studied over 400 patients diagnosed and registered for treatment in a hospital in Hossana Hospital in southern Ethiopia over a two-year period. Using questionnaires they recorded information about the patients' circumstances. They recorded who completed or failed to complete treatment and analysed their data to determine which factors were most closely associated with failure to complete.
The overall completion rate was 80% (i.e. 20% failed to complete), still some way short of the WHO target. The patients who needed to use public transport, which is expensive for many Ethiopians, in order to reach a treatment centre were the most likely to fail to complete. This was despite the fact most of the patients in the study lived in less remote areas than the majority of southern Ethiopians. Other factors were also noted; for example people aged over 25 were less likely to finish their treatment.
The researchers concluded that it will be necessary for the Ethiopian government to continue to expand its efforts to improve access to treatment centres for patients with TB.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Citation: Shargie EB, LindtjГёrn B (2007) Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in southern Ethiopia. PLoS Med 4(2): e37.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Estifanos Shargie
Centre for International Health,
University of Bergen
Bergen, Norway
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/
Contact: Andrew Hyde
Public Library of Science
Tuberculosis is one of the world's leading causes of death and the number of cases is increasing. Ethiopia is one of the worst affected countries. The treatment recommended by the World Health Organization (WHO) can be very effective for most patients but it does involve taking drugs for at least six months. Patients may find it difficult to complete the full treatment, although it helps to have a system where trained observers help make sure that each patient takes all the necessary pills. WHO promotes this approach - known as DOTS (directly observed treatment short course) - and says national programs should aim for a treatment completion rate of at least 85%. Ethiopia was already known to have made good progress towards this goal during the 1990s. However, the researchers wanted to know why those people still not completing treatment were failing to do so.
They studied over 400 patients diagnosed and registered for treatment in a hospital in Hossana Hospital in southern Ethiopia over a two-year period. Using questionnaires they recorded information about the patients' circumstances. They recorded who completed or failed to complete treatment and analysed their data to determine which factors were most closely associated with failure to complete.
The overall completion rate was 80% (i.e. 20% failed to complete), still some way short of the WHO target. The patients who needed to use public transport, which is expensive for many Ethiopians, in order to reach a treatment centre were the most likely to fail to complete. This was despite the fact most of the patients in the study lived in less remote areas than the majority of southern Ethiopians. Other factors were also noted; for example people aged over 25 were less likely to finish their treatment.
The researchers concluded that it will be necessary for the Ethiopian government to continue to expand its efforts to improve access to treatment centres for patients with TB.
###
Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.
Citation: Shargie EB, LindtjГёrn B (2007) Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in southern Ethiopia. PLoS Med 4(2): e37.
PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT
CONTACT:
Estifanos Shargie
Centre for International Health,
University of Bergen
Bergen, Norway
About PLoS Medicine
PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/
About the Public Library of Science
The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/
Contact: Andrew Hyde
Public Library of Science
Wealthy Nations Launch Vaccine Purchase Plan For Diseases Such As HIV/AIDS, TB, Malaria
Officials from a group of wealthy nations on Friday launched a $1.5 billion plan to provide and develop vaccines for diseases -- including HIV/AIDS, tuberculosis and malaria -- that largely affect developing countries, the New York Times reports (Rosenthal, New York Times, 2/10). Under the program, donor countries will pledge to buy vaccines that are being developed at a preferential price when they are available. This would create a financial incentive for drug companies to develop vaccines for diseases that largely affect developing countries (Kaiser Daily HIV/AIDS Report, 2/8). Italy, Canada, Norway, Russia and the United Kingdom have committed the funding for the program, which was launched in Rome (New York Times, 2/10). The program, known as the Advance Market Commitment, will phase out its funding after seven to 10 years, and vaccine manufacturers will be required to continue selling their products to developing countries at the discounted price that was established during the process. Vaccines must meet the standards of efficacy, safety and cost-effectiveness laid out by the GAVI Alliance, the World Bank and an assessment committee (Falconi, AP/CP/Globe and Mail, 2/9). According to the GAVI Alliance and the World Bank, the program is expected to prevent the deaths of 5.4 million children by 2030. The first phase of the plan will focus on the pneumococcal vaccine, which prevents pneumonia in children (New York Times, 2/10). World Bank President Paul Wolfowitz, who attended the launch, said the plan's success requires that the vaccines reach patients, are administered effectively and their results are monitored. He added that the international community should help developing countries improve health care infrastructures to increase access to services (Castelfranco, VOA News, 12/9).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Related Editorial, Opinion Piece
- Washington Post: Even though the plan is a "relatively cheap, market-based approach" to vaccine development, the U.S. contribution is "[n]otably absent," a Washington Post editorial says. This is a "mistake" that policymakers should "correct as the initiative proceeds," the editorial says (Washington Post, 2/12).
- British Finance Minister Gordon Brown, Independent: The new vaccine purchase plan is a "workable, powerful and cost-effective mechanism" that "turns a vague hope for a medical breakthrough into an immediate reality," Brown writes in an Independent opinion piece. He adds that he believes this year will see a "breakthrough in the way we develop and produce life-saving vaccines" (Brown, Independent, 2/10).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Spray Drying Technique Created For TB Vaccine
Bioengineers and public health researchers have developed a novel spray drying method for preserving and delivering the most common tuberculosis (TB) vaccine. The low-cost and scaleable technique offers several potential advantages over conventional freezing procedures, such as greater stability at room temperature and use in needle-free delivery. The spray drying process could one day provide a better approach for vaccination against TB and help prevent the related spread of HIV/AIDS in the developing world.
The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.
"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuГ©rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."
BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.
"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."
The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.
"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."
Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.
"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."
###
Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.
Contact: Michael Patrick Rutter
Harvard University
The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.
"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuГ©rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."
BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.
"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."
The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.
"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."
Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.
"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."
###
Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.
Contact: Michael Patrick Rutter
Harvard University
FDA Announces Label And Indication Changes For The Antibiotic Ketek
The Food and Drug Administration (FDA) today announced revisions to the labeling for the antibiotic Ketek (telithromycin) designed to improve the safe use of Ketek by patients. The changes include the removal of two of the three previously approved indications - acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis - from the drug's label. The agency has determined that the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity (acquired outside of hospitals or long-term care facilities).
In addition, the agency has worked with the company, Sanofi Aventis, to update the product labeling with a "boxed warning," FDA's strongest form of warning. The warning states that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.
FDA also worked with the manufacturer to develop a Patient Medication Guide - that informs patients about the risk of the drug and how to use it safely. The Medication Guide (an FDA-approved patient information sheet) will be provided to patients with each prescription.
"Today's action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research.
Other labeling changes included in today's action are a strengthened warning section regarding specific drug-related adverse events including visual disturbances and loss of consciousness. Warnings for hepatic toxicity (rare but severe symptoms of liver disease) were strengthened in June 2006.
The joint advisory committee, which met on December 14 and 15, 2006, advised that the available data including data acquired since the initial approval of Ketek support a conclusion that the benefits of Ketek outweigh the risks in patients with community acquired pneumonia, but not for patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis. They also recommended a boxed warning as well as Medication Guide for the drug. The joint panel consisted of FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees.
The antibiotic Ketek was originally approved in 2004 and is manufactured by Sanofi Aventis.
For additional information, visit:
fda.gov/cder/drug/infopage/telithromycin/default.htm
fda.gov
In addition, the agency has worked with the company, Sanofi Aventis, to update the product labeling with a "boxed warning," FDA's strongest form of warning. The warning states that Ketek is contraindicated (should not be used) in patients with myasthenia gravis, a disease that causes muscle weakness.
FDA also worked with the manufacturer to develop a Patient Medication Guide - that informs patients about the risk of the drug and how to use it safely. The Medication Guide (an FDA-approved patient information sheet) will be provided to patients with each prescription.
"Today's action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research.
Other labeling changes included in today's action are a strengthened warning section regarding specific drug-related adverse events including visual disturbances and loss of consciousness. Warnings for hepatic toxicity (rare but severe symptoms of liver disease) were strengthened in June 2006.
The joint advisory committee, which met on December 14 and 15, 2006, advised that the available data including data acquired since the initial approval of Ketek support a conclusion that the benefits of Ketek outweigh the risks in patients with community acquired pneumonia, but not for patients with acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis. They also recommended a boxed warning as well as Medication Guide for the drug. The joint panel consisted of FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory committees.
The antibiotic Ketek was originally approved in 2004 and is manufactured by Sanofi Aventis.
For additional information, visit:
fda.gov/cder/drug/infopage/telithromycin/default.htm
fda.gov
March Is Age-Related Macular Degeneration (AMD) Awareness Month; Experts Say Early Detection Is The Key To Saving Eyesight
Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness in Americans older than 50, affecting more than two million people.
March is AMD Awareness Month, and the American Academy of Ophthalmology wants to remind people that although AMD is incurable, there are new treatments that can usually recover lost vision and prevent further vision loss from the disease.
The Academy encourages those older than 50 to see an ophthalmologist for a comprehensive, dilated eye examination every one to two years to ensure that AMD and other vision-threatening conditions are detected and treated early.
"The key in treating AMD is catching it early; early detection is the best defense against losing your vision," said Academy clinical correspondent Lylas G. Mogk, MD, chair of the Academy's Vision Rehabilitation Committee. "Research continues, and I think we'll see increasingly effective AMD treatments becoming available in the near future."
What is AMD?
AMD, progressive and usually painless, affects the macula, a small, specialized area of the retina, located at the back of the eye and responsible for central vision. AMD causes central vision to blur, but leaves peripheral vision intact.
There are two types of AMD: dry and wet. Approximately 90 percent of people with AMD have the dry form, in which aging changes in the macula result in gradual vision loss.
Although only 10 percent of people with AMD have the wet form, it generally progresses much quicker than the dry form. Wet AMD is characterized by the growth of abnormal retinal blood vessels that leak blood or fluid, causing rapid and severe central vision loss.
Reducing AMD Risk
"The most important risk factors for AMD include smoking, high blood pressure and diet," said Dr. Mogk. "Recommendations for reducing the risk of developing AMD include not smoking; eating a heart-healthy diet rich in fish, fruit and green leafy vegetables; avoiding foods with trans fats; exercising and controlling your blood pressure and weight."
Other risk reducers include:
-- The National Eye Institute's (NEI) Age-Related Eye Disease Study found that high levels of antioxidants and zinc can reduce the risk of vision loss by about 25 percent in patients with "intermediate" AMD in one or both eyes and those with "advanced" AMD in only one eye. (Smokers and ex-smokers should not use beta carotene because studies have shown an association with lung cancer and beta carotene in smokers.) A new study will evaluate the effects of lutein and omega-3 fatty acids.
-- Anti-Vascular Endothelial Growth Factor (VEGF) drugs inhibit the development of unwanted blood vessels that cause wet AMD, and these agents help prevent further visual loss and even improve vision. At the current time, these are injected directly into the eye. Two drugs have already been approved by the FDA, Macugen and Lucentis, and the makers of several others are looking to gain FDA approval.
-- Conventional laser therapy and photodynamic therapy are also treatments for wet AMD and have been approved by the FDA based on studies by the National Eye Institute (NEI).
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons -- Eye M.D.s -- with more than 27,000 members worldwide. Eye health care is provided by the three "O's" -- opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy's Web site at http://www.aao.org.
American Academy of Ophthalmology
http://www.aao.org
March is AMD Awareness Month, and the American Academy of Ophthalmology wants to remind people that although AMD is incurable, there are new treatments that can usually recover lost vision and prevent further vision loss from the disease.
The Academy encourages those older than 50 to see an ophthalmologist for a comprehensive, dilated eye examination every one to two years to ensure that AMD and other vision-threatening conditions are detected and treated early.
"The key in treating AMD is catching it early; early detection is the best defense against losing your vision," said Academy clinical correspondent Lylas G. Mogk, MD, chair of the Academy's Vision Rehabilitation Committee. "Research continues, and I think we'll see increasingly effective AMD treatments becoming available in the near future."
What is AMD?
AMD, progressive and usually painless, affects the macula, a small, specialized area of the retina, located at the back of the eye and responsible for central vision. AMD causes central vision to blur, but leaves peripheral vision intact.
There are two types of AMD: dry and wet. Approximately 90 percent of people with AMD have the dry form, in which aging changes in the macula result in gradual vision loss.
Although only 10 percent of people with AMD have the wet form, it generally progresses much quicker than the dry form. Wet AMD is characterized by the growth of abnormal retinal blood vessels that leak blood or fluid, causing rapid and severe central vision loss.
Reducing AMD Risk
"The most important risk factors for AMD include smoking, high blood pressure and diet," said Dr. Mogk. "Recommendations for reducing the risk of developing AMD include not smoking; eating a heart-healthy diet rich in fish, fruit and green leafy vegetables; avoiding foods with trans fats; exercising and controlling your blood pressure and weight."
Other risk reducers include:
-- The National Eye Institute's (NEI) Age-Related Eye Disease Study found that high levels of antioxidants and zinc can reduce the risk of vision loss by about 25 percent in patients with "intermediate" AMD in one or both eyes and those with "advanced" AMD in only one eye. (Smokers and ex-smokers should not use beta carotene because studies have shown an association with lung cancer and beta carotene in smokers.) A new study will evaluate the effects of lutein and omega-3 fatty acids.
-- Anti-Vascular Endothelial Growth Factor (VEGF) drugs inhibit the development of unwanted blood vessels that cause wet AMD, and these agents help prevent further visual loss and even improve vision. At the current time, these are injected directly into the eye. Two drugs have already been approved by the FDA, Macugen and Lucentis, and the makers of several others are looking to gain FDA approval.
-- Conventional laser therapy and photodynamic therapy are also treatments for wet AMD and have been approved by the FDA based on studies by the National Eye Institute (NEI).
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world's largest association of eye physicians and surgeons -- Eye M.D.s -- with more than 27,000 members worldwide. Eye health care is provided by the three "O's" -- opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy's Web site at http://www.aao.org.
American Academy of Ophthalmology
http://www.aao.org
February 27, 2007
Yellow Fever In Togo
The mass vaccination campaign is scheduled to begin today in Savanes and Kara regions where three cases of yellow fever were laboratory confirmed. Yellow fever reappeared in these regions after an absence of more than 20 years.
The campaign will target children more than 9 months old in 11 districts in these 2 regions. The vaccine (1 500 000 doses) has been provided by the The GAVI Alliance emergency stockpile, through the International Coordinating Group (ICG) on Vaccine Provision for Yellow Fever Control. ECHO has provided funding for the campaign.
An additional two cases of yellow fever were reported at the end of January, one in Kara region(Kozah district) and the other in Maritime region (Lacs district); both cases were laboratory confirmed by Institut Pasteur, Dakar, Senegal.
An investigation was carried out by the Ministry of Health, assisted by the WHO Regional Office for Africa and the WHO country office. Containment measures, including a vaccination campaign in Maritime region are currently being assessed.
For more information
- Yellow fever
Department of Epidemic and Pandemic Alert and Response
http://www.who.int
The campaign will target children more than 9 months old in 11 districts in these 2 regions. The vaccine (1 500 000 doses) has been provided by the The GAVI Alliance emergency stockpile, through the International Coordinating Group (ICG) on Vaccine Provision for Yellow Fever Control. ECHO has provided funding for the campaign.
An additional two cases of yellow fever were reported at the end of January, one in Kara region(Kozah district) and the other in Maritime region (Lacs district); both cases were laboratory confirmed by Institut Pasteur, Dakar, Senegal.
An investigation was carried out by the Ministry of Health, assisted by the WHO Regional Office for Africa and the WHO country office. Containment measures, including a vaccination campaign in Maritime region are currently being assessed.
For more information
- Yellow fever
Department of Epidemic and Pandemic Alert and Response
http://www.who.int
Medical Marijuana Might Reduce Nerve Pain Among People Living With HIV/AIDS, Study Says
Medical marijuana might reduce the pain of peripheral neuropathy, a type of nerve damage, among people living with HIV/AIDS, according to a study published in the Feb. 13 issue of the journal Neurology, the Washington Post reports (Weiss, Washington Post, 2/13). Donald Abrams of the University of California-San Francisco and colleagues examined the effects of smoking medicinal marijuana among people living with HIV/AIDS during a two-year period beginning in May 2003, the San Francisco Chronicle reports (Russell, San Francisco Chronicle, 2/13). Researchers enrolled 50 HIV-positive participants who reported severe foot pain caused either by HIV/AIDS or their medications, according to the Post (Washington Post, 2/13). The participants each spent a week at a secure laboratory at San Francisco General Hospital and were required to stop marijuana use before the start of the study (San Francisco Chronicle, 2/13). The researchers measured baseline pain among the participants by asking them to rank their pain on a scale of one to 100 and by administering two standardized tests involving a small hot iron applied to the skin and hot chili pepper cream (Washington Post, 2/13). Twenty-five participants were randomly chosen to receive active marijuana cigarettes with 3.5% THC, the drug's active ingredient, and 25 received a placebo (San Francisco Chronicle, 2/13). The participants smoked three times daily -- at 8 a.m., 2 p.m. and 8 p.m. -- for five days (Washington Post, 2/13). The study found that after the first cigarette on the first day, at least 50% of participants who received active marijuana reported a 72% reduction in pain (San Francisco Chronicle, 2/13). The researchers recorded a 15% reduction in pain among those who received the placebo cigarette (Vesely, Oakland Tribune, 2/12). Over five days, the median reduction in pain reported by the active marijuana smokers was 34%, compared with 17% in the placebo group, the study found (San Francisco Chronicle, 2/13). The researchers took steps to ensure that the marijuana in the study -- which was grown on the government's official marijuana farm in Mississippi and stored in a locked freezer -- was not used for recreational purposes, according to the Post (Washington Post, 2/13).
Comments, Reaction
The results are "evidence, using the gold standard for clinical research, that cannabis has some medical benefits for a condition that can be severely debilitating," Abrams said (San Francisco Chronicle, 2/13). He added, "I think that there are people out there who say there is no evidence that marijuana is medicine, that this is all just a smoke screen." David Murray, chief scientist for the White House Office of National Drug Control Policy, said the physical pain of people living with HIV/AIDS is an issue of great concern. However, "this particular study is not terribly convincing" because of methodological problems, Murray said (Dunham, Reuters, 2/12). He added, "People who smoke marijuana are subject to bacterial infections in the lungs. Is this really what a physician who is treating someone with a compromised immune system wants to prescribe?" (Elias, AP/Casper Star-Tribune, 2/13). Barbara Roberts -- former interim associate deputy director in the Office of National Drug Control Policy and now with Americans for Safe Access -- said, "This should be a wake-up call for Congress to hold hearings to investigate the therapeutic use of cannabis and to encourage more research" (Washington Post, 2/13). Igor Grant -- director of the University of California Center for Medicinal Cannabis Research, which funded the study -- said that although the study's finding are "very promising," they are not definitive (San Francisco Chronicle, 2/13).
The study is available online.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Brazil To Distribute 10M Condoms Ahead Of Carnival As Part Of HIV Prevention Campaign
The Brazilian Ministry of Health plans to distribute 10 million condoms at no cost ahead of the 2007 Carnival festivities as part of its effort to prevent the spread of HIV and other sexually transmitted infections, ministry officials said on Sunday, the AP/International Herald Tribune reports. According to a 2005 survey released by the health ministry earlier this month, almost one-third of young Brazilians responded that they did not use a condom the last time they had sex because one was not available or they could not afford one. Health Minister Agenor Alvares at a news conference in Rio de Janeiro said, "The idea of this campaign is to show that the joy that comes with Carnival must be accompanied by some precautionary measures." The HIV prevention campaign also will include several nationally broadcast radio and TV advertisements, the official Agencia Brasil news service said. About 15 million condoms have been distributed this year, according to the health ministry. Cardinal Geraldo Majella, president of Brazil's Roman Catholic Bishops Conference, said that he does not believe condom distribution efforts will help curb the spread of HIV in the country. This year's Carnival festivities are scheduled to take place from Feb. 17 to Feb. 20 (Azzoni, AP/International Herald Tribune, 2/11).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Malaysia Could Face Increasing Number Of HIV Cases Without Amplified Control Efforts, Health Official Says
Nearly 300,000 Malaysia residents could become HIV-positive by 2015 unless increased efforts are made to reduce the spread of the virus, Ramlee Rahmat, deputy director-general for Malaysia's Ministry of Health, said on Sunday, the AP/San Jose Mercury News reports. According to the AP/Mercury News, there are about 73,000 HIV-positive people living in Malaysia, 75% of whom are injection drug users and 7% of whom are women. Rahmat said the virus is spreading quickly among IDUs, women, fishermen, truck drivers and factory workers in the country (AP/San Jose Mercury News, 2/11). In addition, the government said that transmission through heterosexual sex is increasing and noted a "worrying trend" of increasing HIV incidence among women in the country (AFP/Yahoo! News, 2/11). According to Rahmat, the government last year launched a five-year national strategic plan to reduce HIV transmission. "We are taking this very seriously," Rahmat said, adding, "If we carry out our plans effectively and the public cooperates with us, we will be successful in curbing the spread of the disease." Rahmat added that the government has increased access to drug substitution therapy and needle-exchange programs among IDUs and has provided no-cost antiretrovirals for women and children at government clinics. UNAIDS in 2006 said that Malaysia was one of several countries in the Asia-Pacific region that risked an escalating number of HIV/AIDS cases among IDUs unless efforts were made to reduce the spread of the disease. According the health ministry, three people die daily from AIDS-related illnesses. The ministry last year warned that the spread of HIV could reverse the country's development during the last 50 years, the AP/Mercury News reports (AP/San Jose Mercury News, 2/11).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
February 26, 2007
Bird Flu Officials And Bernard Matthews Say Consumers Not At Risk
Officials investigating the deadly H5N1 bird flu outbreak at a Bernard Matthews turkey farm in Suffolk, UK, have said that consumers are not at risk of bird flu.
Also, Bernard Matthews, founder and owner of the turkey meat company, has spoken about the situation for the first time this week.
Matthews, who is 77 and now occupies a back seat in the management of the company has come forward to emphasize that there has been no attempt to keep information hidden from the authorities, "They know what we know," he said to the press.
"It's my name on the packet and I wouldn't let it go out to the shelves if I thought there was anything wrong with it," said Matthews.
The Food Standards Agency (UK) has said they could find no evidence that the turkey products the company was voluntarily holding at its cold stores in Suffolk and Chesterfield contained meat from the zone in Hungary that is currently under a restriction order.
The products can now be released into the food chain, the FSA said.
In the meantime the Health Protection Agency (HPA) has completed tests on the three poultry workers who were showing avian flu-like symptoms. A fourth person who was not in direct contact with poultry was also tested as a precaution.
All four patients tested negative for the virus and are now either receiving normal clinical care or have been discharged from hospital.
A flu expert at the HPA, Dr Jonathan Van Tam said that the risk of the workers getting avian flu was very low because they had followed the correct procedures.
He expects more workers will come forward with flu symptoms because that is normal at this time of year. The HPA will continue to offer seasonal flu shots and antivirals to those who may have been exposed to the virus.
The FSA also reported that the State Veterinary Service (SVS, an agency within DEFRA) has permitted the slaughterhouse at the Bernard Matthews Suffolk plant to reopen after it was cleaned and disinfected according to Meat Hygiene Service standards.
The chair of the FSA, Deirdre Hutton said in a prepared statement that the "investigation so far has not found anything that raises the risk to public health."
The FSA emphasized that this is not a food safety issue. Their advice is that "avian flu does not pose a food safety risk for UK consumers."
"It is still a possibility that infected poultry has entered the food chain but the risk to public health remains low," said Ms Hutton.
A full report on the joint investigation by the FSA, the Department of Food and Rural Affairs (DEFRA) and the Health Protection Agency (HPA) is expected to be published tomorrow.
Yesterday authorities in the Netherlands said they would be lifting a ban on allowing poultry to be outdoors. The Dutch agriculture ministry said the ban was put in place following reports that the deadly strain of H5N1 had arrived in Britain via wild birds.
They said "It can be said with relative certainty that the outbreak in England came about through indirect contact with infected companies in Hungary. The option that the outbreak was due to infected wild birds seems less likely."
The ban will be lifted on 19th February.
The European Food Safety Authority (EFSA) say that the risk of catching the deadly strain of bird is very very small. Only people who have direct frequent contact with infected live birds carry any significant risk of contracting the disease and regulations about hygiene and handling of live birds should be followed to reduce that risk even further.
The EFSA has issued advice (October 2005) on the importance of thoroughly cooking poultry and eggs.
Poultry includes turkey, chicken, duck, goose, and guinea fowl.
Click here for the Food Standards Agency (UK).
Click here for Avian Influenza: Protecting human health from farm to fork (includes link to 7 min Video, World Health Organization)
Written by: Catharine Paddock
Writer: Medical News Today
Slander Hearing Against Bulgarian Nurses Sentenced To Death In HIV Infection Case Postponed
A hearing in the slander trial brought against five Bulgarian nurses sentenced to death for allegedly intentionally infecting hundreds of Libyan children with HIV has been postponed until later this month, the nurses' lawyer said on Sunday, Reuters UK reports (Reuters UK, 2/11). The five nurses and a Palestinian doctor in May 2004 were sentenced to death by firing squad for allegedly infecting 426 children through contaminated blood products at Al Fateh Children's Hospital in Benghazi, Libya. They also were ordered to pay a total of $1 million to the families of the HIV-positive children. The Libyan Supreme Court in December 2005 overturned the medical workers' convictions and ordered a retrial in a lower court. A court in Tripoli, Libya, in December 2006 convicted the health workers and sentenced them to death. The health workers say they are innocent of the charges, claiming that they were forced to confess and that they were tortured by Libyan officials during interrogations. A Libyan court in June 2005 acquitted nine police officers who had been charged with torturing the medical workers and forcing them to confess (Kaiser Daily HIV/AIDS Report, 2/1). Libyan police officer Juma Mishri and a doctor, Abdulmajid Alshoul, are asking for $3.9 million each in compensation for the nurses' torture accusations. The nurses' lawyer, Othman Bizanti, said they were scheduled to be questioned about the slander charges on Sunday at the start of the new criminal trial, but the Tripoli district court granted his request for more time to study the case. The court has set the questioning for Feb. 25, he said (Reuters UK, 2/11). Sofia, Bulgaria, prosecutor Nikolay Kokinov has said the country within four months will bring charges against 11 Libyan police officers for allegedly torturing the nurses into confessing. Kokinov said the charges would allow him to begin a judicial investigation, which could lead to a trial (Kaiser Daily HIV/AIDS Report, 2/1).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Pennsylvania Health Department Investigates Salmonella Cases Linked To Peanut Butter As Part Of National Outbreak
Due to risk of contamination with salmonella, state Health Secretary Dr. Calvin B. Johnson today advised consumers not to eat and to discard Peter Pan Peanut Butter and Great Value Peanut Butter with product codes that begin with the number "2111."
Nationwide, 288 cases of illness have been linked to the current multi- state salmonella outbreak. In Pennsylvania, 25 cases have been identified in 19 counties: Adams, Beaver, Bedford, Bradford, Bucks, Centre, Clearfield, Dauphin, Elk, Erie, Lackawanna, Lancaster, Lehigh, Luzerne, Montour, Perry, Philadelphia, Tioga, and Wayne.
"The department is working very closely with the federal Centers for Disease Control and Prevention to conduct local public health investigations," Dr. Johnson said. "If you have any Peter Pan or Great Value Peanut Butter at home, check the product codes for '2111.' If those numbers appear, do not eat the peanut butter and immediately discard it."
Salmonella is a bacterial infection that affects the intestinal tract and can sometimes affect the bloodstream and other organs. It is one of the most common causes of gastroenteritis, which can include diarrhea and vomiting. Approximately 2,000 cases of salmonella are reported each year in Pennsylvania.
Onset of illness usually occurs in 24 to 72 hours and patients typically recover in 5 to 7 days. Patients often do not require treatment unless they become severely dehydrated or the infection spreads from the intestines. People with severe diarrhea may require rehydration, often with intravenous fluids. Antibiotics are not usually necessary unless the infection spreads from the intestines.
If you have consumed Peter Pan or Great Value Peanut Butter and are experiencing the symptoms described above, contact your primary health care provider.
Pennsylvania Department of Health
http://www.health.state.pa.us
Nationwide, 288 cases of illness have been linked to the current multi- state salmonella outbreak. In Pennsylvania, 25 cases have been identified in 19 counties: Adams, Beaver, Bedford, Bradford, Bucks, Centre, Clearfield, Dauphin, Elk, Erie, Lackawanna, Lancaster, Lehigh, Luzerne, Montour, Perry, Philadelphia, Tioga, and Wayne.
"The department is working very closely with the federal Centers for Disease Control and Prevention to conduct local public health investigations," Dr. Johnson said. "If you have any Peter Pan or Great Value Peanut Butter at home, check the product codes for '2111.' If those numbers appear, do not eat the peanut butter and immediately discard it."
Salmonella is a bacterial infection that affects the intestinal tract and can sometimes affect the bloodstream and other organs. It is one of the most common causes of gastroenteritis, which can include diarrhea and vomiting. Approximately 2,000 cases of salmonella are reported each year in Pennsylvania.
Onset of illness usually occurs in 24 to 72 hours and patients typically recover in 5 to 7 days. Patients often do not require treatment unless they become severely dehydrated or the infection spreads from the intestines. People with severe diarrhea may require rehydration, often with intravenous fluids. Antibiotics are not usually necessary unless the infection spreads from the intestines.
If you have consumed Peter Pan or Great Value Peanut Butter and are experiencing the symptoms described above, contact your primary health care provider.
Pennsylvania Department of Health
http://www.health.state.pa.us
Researchers Discover New Details About HIV-1 Entry And Infection
The primary targets of HIV-1 infection in the human vagina have been definitively identified in a new study published in the February 2007 issue of the journal Immunity, published by Cell Press. The findings are likely to guide development of new strategies that will prevent HIV-1 transmission.
"The majority of HIV-1 infected individuals worldwide are women who acquire HIV infection following sexual contact," said study authors Florian Hladik, M.D., Ph.D.; and M. Juliana McElrath, M.D., Ph. D, both of Fred Hutchinson Cancer Research Center. "Blocking HIV transmission and local spread in the female lower genital tract is key to prevent infection and ultimately to ease the pandemic."
Hladik and colleagues in the McElrath laboratory developed a unique model system to study the precise mechanisms by which HIV-1 enters the lower reproductive tract of human females. The researchers separated and removed the outer lining of vaginal cells, which serves as the first barrier to the virus. The isolated preparation of intact, viable, vaginal epithelium permitted examination of immune cells that normally migrate out of the vaginal epithelium into deeper tissues shortly after exposure to HIV-1.
The researchers found that HIV-1 simultaneously enters two different types of intraepithelial cells associated with the immune system, Langerhans cells (LC) and CD4+ T cells. However, the path of entry and rate of infection was different for the two cell types. Infection of CD4+ T cells appears to rely at least in part on expression of major HIV-1 coreceptors such as CCR5, whereas pathways for infection of vaginal LC appear to be more diverse and complex. In contrast to previous studies, infection of CD4+ T cells does not appear to require passage of the virus from LC.
Both LC and CD4+ T cells can migrate out of the vaginal epithelium. Study findings suggest that CD4+ T cells may be principally responsible for local shedding of the virus in the vagina of women infected with HIV-1 while LC may harbor viable virus for some time before spreading it to other cells.
These results reveal that it is necessary to consider mechanisms of viral entry into both CD4+ T and LC when searching for an effective way to interfere with infection through the vaginal epithelium.
"Our findings provide exciting definitive insights into the initial events of HIV-1 infection in the human vagina, which can guide the design of effective strategies to block local transmission and prevent HIV-1 spread," McElrath said.
The study was supported by NIH grants AI51980, HD51455 (F.H.), AI35605 (M.J.M.), and AI27757 (University of Washington CFAR); a Burroughs Wellcome Translational Research Award (M.J.M.); and the James B. Pendleton Trust (F.H. and M.J.M.). Publishing in Immunity, Vol. 26, Issue 2 February, 2007. http://www.immunity.com.
McElrath is a member of the Clinical Research Division and the program in infectious diseases at the Hutchinson Center, as well as a professor of allergy and infectious diseases at the University of Washington School of Medicine. Hladik is an associate in clinical research at the Center and a research assistant professor of medicine and allergy and infectious diseases at the University of Washington School of Medicine.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit http://www.fhcrc.org.
Fred Hutchinson Cancer Research Center
http://www.fhcrc.org/
"The majority of HIV-1 infected individuals worldwide are women who acquire HIV infection following sexual contact," said study authors Florian Hladik, M.D., Ph.D.; and M. Juliana McElrath, M.D., Ph. D, both of Fred Hutchinson Cancer Research Center. "Blocking HIV transmission and local spread in the female lower genital tract is key to prevent infection and ultimately to ease the pandemic."
Hladik and colleagues in the McElrath laboratory developed a unique model system to study the precise mechanisms by which HIV-1 enters the lower reproductive tract of human females. The researchers separated and removed the outer lining of vaginal cells, which serves as the first barrier to the virus. The isolated preparation of intact, viable, vaginal epithelium permitted examination of immune cells that normally migrate out of the vaginal epithelium into deeper tissues shortly after exposure to HIV-1.
The researchers found that HIV-1 simultaneously enters two different types of intraepithelial cells associated with the immune system, Langerhans cells (LC) and CD4+ T cells. However, the path of entry and rate of infection was different for the two cell types. Infection of CD4+ T cells appears to rely at least in part on expression of major HIV-1 coreceptors such as CCR5, whereas pathways for infection of vaginal LC appear to be more diverse and complex. In contrast to previous studies, infection of CD4+ T cells does not appear to require passage of the virus from LC.
Both LC and CD4+ T cells can migrate out of the vaginal epithelium. Study findings suggest that CD4+ T cells may be principally responsible for local shedding of the virus in the vagina of women infected with HIV-1 while LC may harbor viable virus for some time before spreading it to other cells.
These results reveal that it is necessary to consider mechanisms of viral entry into both CD4+ T and LC when searching for an effective way to interfere with infection through the vaginal epithelium.
"Our findings provide exciting definitive insights into the initial events of HIV-1 infection in the human vagina, which can guide the design of effective strategies to block local transmission and prevent HIV-1 spread," McElrath said.
The study was supported by NIH grants AI51980, HD51455 (F.H.), AI35605 (M.J.M.), and AI27757 (University of Washington CFAR); a Burroughs Wellcome Translational Research Award (M.J.M.); and the James B. Pendleton Trust (F.H. and M.J.M.). Publishing in Immunity, Vol. 26, Issue 2 February, 2007. http://www.immunity.com.
McElrath is a member of the Clinical Research Division and the program in infectious diseases at the Hutchinson Center, as well as a professor of allergy and infectious diseases at the University of Washington School of Medicine. Hladik is an associate in clinical research at the Center and a research assistant professor of medicine and allergy and infectious diseases at the University of Washington School of Medicine.
At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Our researchers, including three Nobel laureates, bring a relentless pursuit and passion for health, knowledge and hope to their work and to the world. For more information, please visit http://www.fhcrc.org.
Fred Hutchinson Cancer Research Center
http://www.fhcrc.org/
NanoBio(R) Corporation Initiates Phase 2b Clinical Trial For Herpes Labialis Treatment
NanoBio(R) Corporation, a biopharmaceutical company developing novel products for the treatment and prevention of topical infections, today announced that it has begun enrolling patients in its Phase 2b study of NB-001, a drug candidate for the topical treatment of Herpes labialis. The Phase 2b trial is a randomized, placebo- controlled study at 30 sites in the United States, where 1,000 potential subjects are being recruited.
"We are pleased to be able to move NB-001 into the next stage of clinical development," stated Dr. James Baker, NanoBio's Chairman of the Board and Chief Science Officer. "Given the remarkable safety profile of NB-001 and the clear efficacy demonstrated in our prior trial, we are now able to perform a Phase 2b study with doses that are three and five times higher then previously used."
Dr. Baker added, "NB-001 safely and effectively targets the Herpes virus when applied to the skin, thus making it a promising topical treatment for Herpes labialis. Its novel mechanism of action leaves little risk of drug resistance, which is a concern with the systemic anti-viral therapies used to treat this disease. These attributes may eventually allow NB-001 to be sold without a prescription."
Summary of NanoBio's Previous Clinical Studies for NB001
In 2005, NanoBio completed a Phase 2 study of NB-001 for the treatment of Herpes labialis. The trial was a multi-center, randomized, placebo-controlled study in the United States, involving 332 subjects. When compared to a placebo, a substantially higher proportion of subjects receiving NB-001 healed within three days (17% vs 2%, p=0.0046) or four days (25% vs. 10%, p=0.036). Also, the time it took for sores to heal in NB-001-treated subjects was shortened by over a day (6.26 days treated vs. 7.42 days untreated). No drug- related adverse events, no skin irritation, and no systemic absorption of NB- 001 were observed.
About NanoBio Corporation
NanoBio(R) Corporation is a privately-held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat(TM) technology platform. The company's lead product candidates for the treatment of Herpes labialis (cold sores) and onychomycosis (nail fungus) are in clinical trials. In addition, preclinical work is ongoing for a treatment for methicillin resistant Staphylococcus aureus (MRSA), and mucosal vaccines for influenza and Hepatitis B. The company's headquarters and laboratory facilities are located in Ann Arbor, Michigan.
About Herpes Labialis
Cold sores or fever blisters on the lips or surrounding skin are predominantly caused by the Herpes simplex I (HSV1) virus. Approximately 80% of all Americans are infected with HSV1 and approximately 20% to 40% of adults suffer from recurrent outbreaks of cold sores. While not life-threatening, these attacks can be painful and unsightly, and are highly contagious. The global market for Herpes labialis treatments is expected to grow to $1.7 billion annually when NB-001 is targeted to reach the market in 2010-2011.
NanoBio Corporation
http://www.nanobio.com/
"We are pleased to be able to move NB-001 into the next stage of clinical development," stated Dr. James Baker, NanoBio's Chairman of the Board and Chief Science Officer. "Given the remarkable safety profile of NB-001 and the clear efficacy demonstrated in our prior trial, we are now able to perform a Phase 2b study with doses that are three and five times higher then previously used."
Dr. Baker added, "NB-001 safely and effectively targets the Herpes virus when applied to the skin, thus making it a promising topical treatment for Herpes labialis. Its novel mechanism of action leaves little risk of drug resistance, which is a concern with the systemic anti-viral therapies used to treat this disease. These attributes may eventually allow NB-001 to be sold without a prescription."
Summary of NanoBio's Previous Clinical Studies for NB001
In 2005, NanoBio completed a Phase 2 study of NB-001 for the treatment of Herpes labialis. The trial was a multi-center, randomized, placebo-controlled study in the United States, involving 332 subjects. When compared to a placebo, a substantially higher proportion of subjects receiving NB-001 healed within three days (17% vs 2%, p=0.0046) or four days (25% vs. 10%, p=0.036). Also, the time it took for sores to heal in NB-001-treated subjects was shortened by over a day (6.26 days treated vs. 7.42 days untreated). No drug- related adverse events, no skin irritation, and no systemic absorption of NB- 001 were observed.
About NanoBio Corporation
NanoBio(R) Corporation is a privately-held biopharmaceutical company focused on developing and commercializing anti-infective products and mucosal vaccines derived from its patented NanoStat(TM) technology platform. The company's lead product candidates for the treatment of Herpes labialis (cold sores) and onychomycosis (nail fungus) are in clinical trials. In addition, preclinical work is ongoing for a treatment for methicillin resistant Staphylococcus aureus (MRSA), and mucosal vaccines for influenza and Hepatitis B. The company's headquarters and laboratory facilities are located in Ann Arbor, Michigan.
About Herpes Labialis
Cold sores or fever blisters on the lips or surrounding skin are predominantly caused by the Herpes simplex I (HSV1) virus. Approximately 80% of all Americans are infected with HSV1 and approximately 20% to 40% of adults suffer from recurrent outbreaks of cold sores. While not life-threatening, these attacks can be painful and unsightly, and are highly contagious. The global market for Herpes labialis treatments is expected to grow to $1.7 billion annually when NB-001 is targeted to reach the market in 2010-2011.
NanoBio Corporation
http://www.nanobio.com/
New York City To Unveil Official Condom As Part Of HIV Prevention Efforts
New York City health officials on Wednesday are scheduled to unveil the city's official condom as part of the New York City Department of Health and Mental Hygiene's efforts to curb the spread of HIV and other sexually transmitted infections, the AP/Long Island Newsday reports (Kugler, AP/Long Island Newsday, 2/13). The health department last month approved a $1.57 million contract to deliver more than 20 million Ansell Healthcare's Lifestyle condoms and packets of lubricants to organizations and venues in the city to help curb the spread of HIV. The health department will pay Ansell four cents per condom, putting the cost of the program at about $720,000 annually, according to health officials. Officials are attempting to make the packaging for the condoms, which will be distributed by the city, more distinctive. City officials said they hope the condom's packaging will help them to better track the effectiveness of their distribution program (Kaiser Daily HIV/AIDS Report, 1/29). According to the AP/Newsday, the condoms' design is expected to be a subway theme with different colors for various train lines (AP/Long Island Newsday, 2/13). Officials plan to track the progress of the program through an annual community health survey, which polls 10,000 city residents by telephone. New York City currently distributes about 1.5 million condoms monthly, or about 18 million annually, at no cost to organizations, health clinics, advocacy groups, bars, restaurants, nail salons, nightclubs and prisons. Organizations or venues can request an unlimited supply of condoms at no cost through an online ordering system set up by the city health department (Kaiser Daily HIV/AIDS Report, 1/29). Volunteers are scheduled to hand out the no-cost condoms at the launch, which will take place at a Kenneth Cole store in Manhattan. The store also plans to unveil a T-shirt and boxer shorts as part of the campaign (AP/Long Island Newsday, 2/13).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
February 23, 2007
Rev. Jesse Jackson Urges HIV Awareness, Testing, More Research For A Cure At National Black AIDS Conference
The Rev. Jesse Jackson on Monday in Philadelphia at the 2007 National Conference on African-Americans and AIDS called for increased research funding to find a cure for HIV/AIDS, as well as more awareness about HIV testing, the Philadelphia Inquirer reports (McCullough, Philadelphia Inquirer, 2/13). Jackson, founder of the RainbowPUSH Coalition, gave the plenary address at the two-day conference. The conference, which ended Tuesday, featured discussions such as "Epidemiology of HIV"; "Clinical Management of HIV Infection"; "Microbicides"; "Hepatitis A, B and C"; and "HIV/AIDS Policy" (Williams, Philadelphia Daily News, 2/13). Jackson encouraged well-known blacks to receive HIV tests publicly to help address the stigma surrounding the disease. For instance, he said that if players participating in the National Basketball Association All-Star Game on Sunday took the test live on television, it could inspire others to do the same. "We must use every platform we can for mass education," Jackson said. He also urged the hundreds of medical professionals and HIV/AIDS advocates attending the conference to buy stock in drug companies and then attend shareholder meetings to push for a cure, according to the Inquirer. The drug companies GlaxoSmithKline, Bristol-Myers Squibb and Pfizer are among major sponsors of Minority Healthcare Communications, which produces the conference, the Inquirer reports. Drug companies "may have an interest in more medicine and less cure," Jackson said, adding, "Ultimately we don't want the medicine. We want the cure" (Philadelphia Inquirer, 2/13).
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.