By: Jessica Grogan, MDNews.com
Thursday, December 29, 2011
The U.S. Food and Drug Administration has approved Phase I human clinical trials for a Canadian vaccine designed to prevent HIV.
A team of researchers led by Dr. Chil-Yong Kang at the University of Western Ontario developed the SAV001 vaccine, with the support of Sumagen Canada. The team plans to begin Phase I of clinical trials on 40 HIV-positive patients in January 2012. The FDA has given the green light to test the safety, not the effectiveness, of the vaccine.
The SAV001 vaccine is based on a genetically modified killed whole virus and not a live virus. In preliminary toxicology tests, the vaccine has been shown to stimulate a strong immune response. If found safe, two more clinical trials will be conducted. Dr. Kang estimates it will cost $100 million to complete those two trials.
Phase II would look at the immune responses and see whether they make antibodies against the virus. This trial would be conducted on roughly 600 subjects who are HIV-negative but whose lifestyle puts them at high risk of contracting the disease.
Phase III would test the effectiveness of the vaccine in a larger at-risk group. Researchers hope to recruit about 6,000 volunteers for the final phase; half of the individuals would be vaccinated and half would not.
Dr. Kang said participants in the study would be tracked for three years to see how many become infected with the virus.
“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 Dr. Kang in a press release.