Researchers at the University of Western Ontario have been given the green light by the U.S. Food and Drug Administration to start the first human trials of a vaccine that could prevent someone from getting HIV.
Although the trials will only determine if the vaccine is safe -- not how effective it is -- lead researcher Dr. Chil-Yong Kang considers the approval to conduct a human trial with the vaccine a triumph thus far.
“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, professor at Western's Schulich School of Medicine & Dentistry, in the press release.
The university, along with Sumagen Canada, created the first vaccine of its kind in Canada -- one of only a few being developed in the world -- from a genetically modified, killed whole virus. Preliminary lab results show a good immune response and no negative side effects.
With the 30-year anniversary of the virus' discovery little more than a year away, more than 28 million people have died from HIV/AIDS and more than 35 million currently live with the disease. Here Kang explains the trial and its significance:
According to the release, the SAV001 vaccine trials will be conducted in three phases:
- Phase I, set to begin in January 2012, will double check the safety of the vaccine in humans, involving only 40 HIV-positive volunteers.
- Phase II will measure immune responses in humans, involving approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection.
- Phase III will measure the efficacy of the vaccine, involving approximately 6,000 HIV-negative volunteers who are also in the high-risk category for HIV infection.
The Montreal Gazette (via Gizmodo) reports that Kang told Postmedia News that if everything goes well with the trials a commercial vaccine would still be at least five years away. The Gazette reports that the trials will be taking place in the U.S. at select facilities with capability to conduct such trials.
As Kang said in the video, the vaccine is made much in the same way other common vaccines, such as the polio and smallpox vaccine. The whole HIV-1 virus is killed with chemicals and radiation and modified to not infect patients.
"So we infect the cells with a virus and then the infected cells will produce lots of virus and we can collect them, purify them and then inactivate them," Kang said in the video.