Canadian researcher gets FDA approval for HIV vaccine trial
The FDA has granted University of Western Ontario researchers approval to start human trials of their HIV vaccine. Even though Dr. Chil-Yong Kang and his team trail others in their field who have already begun clinical trials of HIV vaccines, Kang is confident his approach could be the key to cracking the tricky HIV virus code.
Kang's method is similar to that used for polio, rabies, flu and other vaccines. "These diseases are all prevented by the killed whole virus. However, none of the researchers in the past have used this approach to develop HIV vaccines," he explained.
Rather than trying to use pieces of the HIV virus, Kang's team genetically modified a killed whole HIV virus, making it safe to inject into humans. Researchers were previously concerned both about the potential danger of using killed whole viruses, as well as the manufacturing complexity of such an approach. But Kang's team used chemicals and gamma rays to render the virus harmless, and in the process engineered the virus in such a way as to allow for large-scale manufacturing.
Phase I testing of the vaccine, dubbed SAV001, is expected kick off in January 2012. Kang noted the shot has already shown it's capable of stimulating a strong immune response in preliminary toxicology 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," he added in a release.