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FDA Approves HIV Vaccine for Human Trials

An HIV vaccine developed by researchers from the University of Western Ontario (UWO) was recently approved by the U.S. Food and Drug Administration (FDA) for clinical trials in humans.


A team led by Chil-Yong Kang, PhD, a researcher and professor at UWO’s Schulich School of Medicine & Dentistry, created the unique vaccine, known as SAV001, by using a killed whole HIV-1 similar to the killed whole virus vaccines for hepatitis A and influenza. The virus is genetically engineered so that it does not cause disease and can be generated in large volumes. SAV001 is being developed with the support of Sumagen Canada Inc., a subsidiary of Sumagen Co., Ltd., a Korea-based pharmaceutical company specializing in HIV vaccines.


The SAV001 vaccine still needs to pass through the following three phases of human clinical trials before it becomes commercially available:


  • Phase I, which begins this month, double checks the safety of the vaccine in 40 HIV-positive volunteers.
  • Phase II will measure immune responses in approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection.
  • Phase III will measure the efficacy of the vaccine in approximately 6,000 HIV-negative volunteers in the high-risk category for 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,” said Kang.


Source: The University of Western Ontario press release dated December 20, 2011


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