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Researchers in the U.S. and Africa today announced the launch of the first large-scale HIV vaccine study. The trial is slated to take four years and enroll up to 3,000 participants in five clinics throughout South Africa.
The study will help researchers to determine whether the test vaccine prevents HIV infection, results in lower HIV levels in those who become infected after vaccination, or both. In addition, investigators will determine whether this vaccine, based on clade B HIV, has the potential to protect against the clade C virus, the subtype prevalent in South Africa.
Additionally, the South African study may yield information on how the test vaccine could work in a predominantly heterosexual HIV epidemic, how responsive women are to the vaccine, and whether the vaccine works in populations already immune to the virus used in the vaccine.
"South Africa is an excellent location for this trial due to the high levels of infection coupled with the good clinical infrastructure, including internationally recognized immunology laboratories, a well-established national vaccine initiative, and experience in running clinical trials," said James Kublin, MD, MPH, a staff physician in the Hutchinson Center's Clinical Research Division and one of the study's lead investigators, in a statement. "Community involvement and education initiatives in South Africa are robust and mature, and they are essential for running trials involving thousands of volunteers."
The test vaccine, known as the MRKAd5 HIV-1 trivalent vaccine, is manufactured by Merck & Co., and already has been determined to be safe and stimulate immune response against HIV in half of volunteers in its phase I and II trials. (The Advocate)
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