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.