HIV/AIDS Vaccine Candidates Enter Crucial Stage As Clinical Trials End, IAVI Head Says

Experimental HIV/AIDS vaccines under development by Merck and Sanofi-Aventis are entering crucial stages, and results from clinical trials for both vaccine candidates are expected in 2008, Seth Berkley, head of the International AIDS Vaccine Initiative, said in an interview ahead of the World Economic Forum in Davos, Switzerland, Reuters Health reports (Hirschler, Reuters Health, 1/23). Berkley in August 2006 said that both companies each have a vaccine candidate in late-stage human trials. He added that the "next major milestone for the field is likely to be the Merck result, which is a test for cellular immunity." Merck's vaccine, which of all the vaccines in development is in the most advanced testing stages, works by improving the ability of CD4+ T cells to "seek and destroy [HIV-]infected human cells" to "prevent HIV ... from causing disease." The company expects by 2008 or 2009 to have some data on the vaccine and plans to conduct a clinical trial of about 3,000 people in Australia, the Caribbean and North and South America. Berkley said that if the Merck vaccine reduces the expected number of new HIV cases even slightly, researchers will be able to evaluate the trial participants and use their findings to guide future research. If the vaccine is not at all effective, researchers will have to look at different approaches. GlaxoSmithKline also is working on a vaccine, which is in early stages of testing (Kaiser Daily HIV/AIDS Report, 8/16/06). "Next year is a pretty important year," Berkley said, adding, "If we have an intermediate result [from the trials], it is still very, very important because it allows us to validate the animal models and really improve on it." More effort is needed to research other approaches, such as neutralizing antibodies, according to Berkley. He added that positive steps are being made in terms of research and the increasing number of clinical trials worldwide. "Do I think we are going to solve this at the end of the day? Absolutely," Berkley said, adding, "If you go back 10 years, it was a bleak as could be. Ten years later, we have a wide pipeline; we have multiple efficacy trials; everybody making vaccines is considering the needs of the developing world; there is political leadership; and there has been a 500% increase in money" (Reuters Health, 1/23).

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