FDA approves first HIV/AIDS vaccine for human clinical trials

The FDA has approved the first preventive HIV vaccine to begin human clinical trials in January, according to a press release from the University of Western Ontario in Canada.

The vaccine (SAV001) was developed by Chil-Yong Kang, PhD, researcher and professor at the University of Western Ontario Schulich School of Medicine & Dentistry, and colleagues, with the support of Sumagen Canada.

“FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection,” Kang said in the release.

In preliminary toxicology tests, the vaccine — manufactured at a biosafety level 3 (BSL3) good manufacturing practice (GMP) facility in the United States, stimulated strong immune responses with no adverse effects or safety risks, according to the researchers.

The vaccine will undergo the following three phases of human clinical trials:

Phase 1 is scheduled to being in January and will double-check the safety of the vaccine in humans, involving 40 HIV-positive volunteers.
Phase 2 will measure immune responses in humans, involving approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection.
Phase 3 will measure the efficacy of the vaccine, involving approximately 6,000 HIV-negative volunteers who also are in the high-risk category for HIV infection.

It is the only HIV vaccine currently under development in Canada, and one of only a few in the world, according to the release.

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