HIV Vaccine Trial Approved By FDA
NEWS, 26 Dec 2011
Canadian-developed vaccine to start human clinical trials in January 2012.
A vaccine that may prevent HIV has been given the green light by the U.S. Food and Drug Administration to begin clinical trials in humans, according to Canadian researchers.
The announcement was made on the campus of the University of Western Ontario in London, Ont.
“We have gone through so many different challenges to come to this point,” said Dr. Chil-Yong Kang, a researcher and professor at Western’s Schulich School of Medicine and Dentistry. “This is the first time that I feel very happy and comfortable to initiate this human clinical trial.”
Scientists at the University of Western Ontario, financially backed by the pharmaceutical venture company Sumagen, developed the vaccine, which is based on a genetically modified killed whole virus. The vaccine stimulated a strong immune response in early testing and appears to have no adverse effects, according to the researchers.
“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.
He said there have been three clinical trials for an HIV vaccine in the past using live viruses. “None of the researchers in the past have used this approach,” he says of his use of a killed virus.
The vaccine, SAV001, will now have to undergo three phases of human clinical trials;
- 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.
DISCLAIMER: The statements, views and opinions expressed in pieces republished here are solely those of the authors and do not necessarily represent those of TMS. In accordance with title 17 U.S.C. section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. TMS has no affiliation whatsoever with the originator of this article nor is TMS endorsed or sponsored by the originator. “GO TO ORIGINAL” links are provided as a convenience to our readers and allow for verification of authenticity. However, as originating pages are often updated by their originating host sites, the versions posted may not match the versions our readers view when clicking the “GO TO ORIGINAL” links. This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe this constitutes a ‘fair use’ of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/107.shtml. If you wish to use copyrighted material from this site for purposes of your own that go beyond ‘fair use’, you must obtain permission from the copyright owner.