FDA approves HIV vaccine for human trials
The US Food and Drug Administration (FDA) has approved clinical human trials for an experimental HIV vaccine that was developed by researchers at the University of Western Ontario with the support of Sumagen Canada.
Dr. Chil-Yong Kang, a professor at the Schulich School of Medicine and Dentistry, and his team will start the first human trials of an HIV vaccine that could prevent individuals from getting the virus, according to a press release from the University of Western Ontario.
According to the release, the new HIV vaccine, SAV001, is based on a genetically engineered killed whole virus and has already proven to stimulate strong immune responses in preliminary tests with no adverse effects or safety risks.
“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 press release.
Human trials will be conducted in three phases. In the first phase, set to begin in January 2012, the HIV vaccine will be tested on 40 HIV-positive volunteers in order to check the safety of the vaccine in humans. In the second phase, the vaccine will be tested on approximately 600 HIV-negative volunteers who are at high-risk for contracting HIV in order to measure immune responses in humans. In the third and final phase, the vaccine will be used on approximately 6,000 HIV-negative volunteers who are also fall into the high-risk category to again measure the efficacy of the vaccine. The results of all phases will be examined by the FDA, who will decide on the vaccine’s efficiency.
According to figures from the Joint United Nations Programme on HIV/AIDS (UNAIDS), more than 28 million people have died from HIV/AIDS since 1983 when the virus was first characterized and more than 35 million people worldwide are currently living with the viral infection.
Resource: Today’s Zaman