The world´s first human test of a vaccine against the prevalent subtype of HIV in sub-Saharan African and Asia, where millions have the virus that causes AIDS, is now under way. The clinical trial uses novel technology pioneered by scientists at the University of North Carolina at Chapel Hill School of Medicine and the U. S. Army Medical Research Institute of Infectious Diseases.
The phase I trial began July 17 at Johns Hopkins University. An adult male, at low risk for HIV infection, was the first of 48 volunteers in the United States to be vaccinated.
Other U.S. sites include Columbia University, Vanderbilt University and the University of Rochester. Sites in South Africa are at the University of Witwatersrand, the Chris Hani Baragwanath Hospital in Soweto and the Medical Research Council in Durban. The two-year trial will involve 48 non-HIV-infected participants in each country at four different dose levels, using a double-blind, placebo-controlled design. The primary endpoint is safety, that the vaccine does not produce significant side effects. Researchers also will look at the vaccine´s ability to induce an immune response.
Leslie Lang | EurekAlert!
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