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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
UNITED STATES; CANADA: Human Clinical Trials of HIV Vaccine to Start in January
Hilary Roberts, Postmedia News
December 21, 2011
Edmonton Journal (12.21.11) - Wednesday, December 21, 2011

Canadian researchers announced on Dec. 20 that a Phase I trial of a vaccine to prevent HIV infection is set to launch in January. The experimental vaccine has been manufactured in the United States, and the research team - led by Dr. Chil-Yong Kang, a virologist at the University of Western Ontario - recently received US Food and Drug Administration approval to begin human trials.

The vaccine is unique in that it uses dead HIV-1 virus, an approach similar to that used for polio and influenza vaccines. The virus is genetically engineered not to cause HIV. Preliminary toxicology tests on animals did not show any adverse effects or safety concerns with the vaccine, called SAV001, and it can be produced in large quantities, Kang said.

"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 inactive them," Kang said.

The Phase I safety trial will involve 40 HIV-positive individuals; it should take six months to complete and a year to evaluate results, Kang said. If the vaccine candidate proves safe, Phase II would be conducted with about 600 HIV- negative high-risk individuals to measure immune system responses. If it advances further, a Phase III trial involving about 6,000 HIV-negative high-risk people would test the vaccine's efficacy using a vaccinated group and a non- vaccinated control group. Dosing schedules would be another variable to evaluate. It could take about five years for the vaccine to reach the market, Kang said.