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The first and only preventative HIV vaccine based on a genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA) to start human clinical trials.
Developed by Dr. Chil-Yong Kang and his team at The University of Western Ontario, with the support of Sumagen Canada, the vaccine (SAV001) holds tremendous promise, having already proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or safety risks. It is the only HIV vaccine currently under development in Canada, and one of only a few in the world.
Dr. Chil-Yong Kang and a team at the university, funded by pharmaceutical venture company Sumagen Canada, said approval by the American agency was crucial and a clinical trial on 40 HIV-positive volunteers will begin next month.
That phase will last a year, after which 600 HIV-negative volunteers will see how the vaccine impacts their immune systems. A final phase, which will take about three years, will involve about 6,000 HIV-negative volunteers.
HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the virus infection.
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