The U.S. Food and Drug Administration has granted permission for a Canadian-based research team to begin a phase I clinical trial on a new HIV vaccine, which has the potential to provide a much-needed breakthrough in the field of HIV prevention.
The vaccine, known as SAV001, was developed by a team of researchers at The University of Western Ontario in London, Ont., who received funding for the project from Sumagen Canada. SAV001 is the first vaccine developed for HIV that uses a whole, killed, genetically modified virus to elicit an immune response. Vaccines previously developed for HIV used a live virus.
The phase I clinical trial is scheduled to begin in January 2012. According to a press release from the Schulich School of Medicine & Dentistry at The University of Western Ontario, the trial will test the safety of the vaccine in a sample population of 40 HIV-positive volunteers. If the vaccine is deemed safe to use, a phase II trial involving 600 HIV-negative participants who are at a high risk of contracting the disease will be conducted to measure the strength of the elicited immune response. A larger phase III trial designed to test the efficacy of the vaccine will then be administered to a sample population of 6,000 HIV-negative, high-risk participants.
According to AIDS.gov, a website maintained by the U.S. Department of Health & Human Services, an estimated 1.1 million Americans live with HIV, and more than 17,000 people die of AIDS each year. The development of SAV001 marks an important achievement in the field of HIV prevention, and early toxicology screenings have been encouraging because the virus was found to elicit a strong immune response with no reported side effects or safety concerns.
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