Canadian researchers have received approval to begin human testing of an experimental HIV vaccine.
The U.S. Food and Drug Administration has given the go-ahead to researchers at the University of Western Ontario to test the vaccine, which is based on a genetically modified killed whole virus.
The researchers say Phase I of the clinical trial, which will begin in January, will test the safety of the vaccine in 40 HIV-positive volunteers.
The SAV001 vaccine, developed by Dr. Chil-Yong Kang and his team with support from Sumagen Canada, has been shown to stimulate a strong immune response in preliminary toxicology tests. If the SAV001 vaccine is found to be safe, it would require two more clinical trials that prove it works before it could be brought to market.
Phase II would measure immune responses to the vaccine in people who are HIV negative but at high risk of infection and Phase III would test the efficacy of the vaccine in a larger group of similarly at-risk individuals.
“FDA approval for human clinical trials is an extremely significant milestone for our vaccine,” Kang said in a statement Tuesday.
HIV-AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the infection. There have been numerous attempts by pharmaceutical companies and academic institutions worldwide to develop vaccines, but no commercialized vaccine has yet been developed.
the Canadian Press & Global News Canada