LONDON, Ont., Canada—Dr. Chil-Yong Kang, a virologist at the University of Western Ontario, and his team of researchers have been given permission by the U.S. Food & Drug Administration (FDA) to begin clinical trials on human subjects of a new vaccine to prevent HIV infection.
"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," Dr. Kang said in a press release. Involving the FDA in the vaccine testing process should also speed up its approval, if successful, for use in the United States.
Dr. Kang's approach is to use actual dead HIV-1 virus material that has been genetically engineered to be non-infectious, similar to the way pharmaceutical companies create polio and flu vaccines by deactivating polio and flu viruses.
The HIV vaccine, dubbed SAV001, has already undergone toxicology testing, which revealed no adverse effects or safety concerns.
"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 posted on the University of Western Ontario's YouTube channel.
He noted that there have already been three clinical trials for an HIV vaccine developed by using live HIV viruses, but none have proven successful.
According to the Canadian Broadcasting Corporation website, the human trials will have three phases:
Phase 1: Beginning in January 2012, this phase will involve 30 HIV-positive people on whom safety will be retested.
Phase 2: This phase will examine immune responses in humans and will involve 600 HIV-negative people who are at high risk of contracting the AIDS virus.
Phase 3: This phase will determine the efficacy of the vaccine and will involve 6,000 HIV-negative volunteers at high risk of contracting the virus.
In other HIV news, Timothy Ray Brown, a 42-year-old lukemia sufferer who had been HIV-positive for more than a decade, remains HIV-free four years after a treatment that involved his being given an experimental transplant of bone marrow with cells that contained an unusual natural variant of the CCR5 cell-surface receptor. The CCR5-Δ32 variant has been shown to make some cells from people who are born with it resistant to infection with some strains of HIV. Brown continues to test negative for the HIV virus four years after the operation, and two years after he stopped taking anti-retroviral drugs, and has been pronounced "cured" by the scientific journal, Blood.