A team led by Dr. Chil-Yong Kang, a virologist at the University of Western Ontario in London, Ont., plans to start Phase 1 of clinical trials on 40 HIV-positive patients to test the safety of the vaccine.
"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 a news release.
It could be about five years before the vaccine goes on the market, Kang told Postmedia News.
The SAV001 vaccine, administered as an injection, has already gone through preliminary toxicology tests on animals. It didn't show any adverse effects or safety concerns and can be produced in large quantities, Kang said.
The vaccine is the only one under development in Canada. It's unique in that it uses a dead HIV-1 virus — similar to vaccines used against polio and influenza — and is genetically engineered to be non-pathogenic, meaning it won't cause HIV in recipients.
"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 a video explaining the vaccine posted on the University of Western Ontario's YouTube channel Tuesday.
The cells are inactivated by chemicals and by radiation, Kang said in the video.
"(The) human body will react to this immunogen and make antibodies and proper immune responses," Kang said in the video.
Kang's team has been working with Sumagen — a South Korean pharmaceutical company that established a Canadian branch in 2008 specifically to support development of this vaccine and has patents for SAV001 in 70 countries, including the U.S. and countries in the European Union.
Clinical trials are scheduled to take place in the U.S., where facilities are already set up, Kang said in an interview.
It should take about six months to complete Phase 1 tests and a year to evaluate the results, he said. Meanwhile, researchers can prepare for Phase 2, which is meant to measure people's immune-system response.
The second phase of clinical trials is expected to involve about 600 HIV-negative people in the high-risk category for HIV infection.
Four groups of people make up the high-risk category, including hemophiliacs, injection drug users, sex trade workers and those in the gay community with multiple sexual partners.
Researchers know the vaccine will pass toxicology tests on humans in Phase 1 because it worked on monkeys and rats without any negative effects, Kang said. They also don't expect any problems passing Phase 2.
The third phase will require about 6,000 HIV-negative people also considered to be in the high-risk category. It will test how effective the vaccine is by comparing a vaccinated and a non-vaccinated group, Kang said in the video.
Researchers can't definitively predict whether the vaccine will prevent HIV in humans until Phase 3 is complete, he said in an interview.
Through the clinical trials, researchers will determine how many injections are needed, Kang said. Two shots given one month apart worked to produce enough antibodies in animals.
Kang has been studying HIV since 1987. The first decade of his work involved understanding the molecular biology of the virus, he said. The next decade focused on developing the vaccine. Kang said he is also working toward a therapeutic vaccine to treat HIV-positive patients.
HIV, the virus that causes AIDS, can be transmitted through unprotected sex, needle-sharing and from an infected mother to her baby through pregnancy, according to Health Canada. There is currently no vaccine and no proven cure for HIV or AIDS.
Between Nov. 1, 1985 and Dec. 31, 2009, there were 69,844 positive HIV tests reported in Canada, according to the Public Health Agency of Canada's most recent surveillance report.
More than 34 million people around the world were living with HIV at the end 2010, according to the United Nations Program on HIV/AIDS.