The U.S. Food and Drug Administrations has approved to begin clinical trials in humans for a vaccine that may prevent HIV!
The announcement was made on the campus of the University of Western Ontario in London, Ont.
“We have gone through so many different challenges to come to this point,” said Dr. Chil-Yong Kang, a researcher and professor at Western’s Schulich School of Medicine and Dentistry. “This is the first time that I feel very happy and comfortable to initiate this human clinical trial.”
In early testing, the vaccine stimulated a strong immune response and appears to have no adverse effects.
“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,” said Kang.
The vaccine is called SAV001 and will undergo three phases of human clinical trials:
Phase 1. Beginning in January 2012, this phase will involve 30 HIV-positive people on whom safety will be retested.
Phase 2. This phase will examine immune responses in humans and will involve 600 HIV-negative people who are at high risk of contracting the AIDS virus.
Phase 3. This phase will determine the efficacy of the vaccine and will involve 6,000 HIV-negative volunteers at high risk of contracting the virus.