HIV Vaccine FDA

December 23, 2011 by staff 

HIV Vaccine FDAHIV Vaccine FDA, The HIV vaccine, called SAV001, is expected to partake in human clinical trials in January 2012, The U.S. Food and Drug Administration has approved the clinical testing of an HIV vaccine on humans that could be available on the market as soon as five years.

Canadian researchers led by Dr. Chil-Yong Kang, a virologist at the University of Western Ontario, created the HIV vaccine, which is called SAV001. SAV001 is administered as an injection, and uses a dead HIV-1 virus that is genetically engineered to be non-pathogenic. This means it won’t cause HIV in those receiving the injection.

Kang described the process as infecting cells with a virus; the infected cells create more of the virus. These cells are then collected, purified and inactivated via chemicals and radiation.

SAV001 has already successfully passed preliminary toxicology tests on animals with no negative side effects, and will now begin clinical trials on humans in January 2012.

“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.

There will be three phases in the human clinical trials. Phase 1, which begins in January, will test the safety of the vaccine on 40 HIV-positive patients and will take about six months to complete. Phase 2 will measure the immune system responses of 600 HIV-negative participants who are at high-risk of contracting HIV, such as injection drug users, hemophiliacs, those in the gay community with several partners, and sex trade workers, according to the Ottawa Citizen.

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