Engineered HIV/AIDS Vaccine Approved for Clinical Trials

Chil-Yong Kang (University of Western Ontario)

A vaccine designed to prevent HIV infection based on a genetically engineered virus has received approval by the U.S. Food and Drug Administration to start clinical trials. The vaccine is a product of a joint venture between Universiy of Western Onatrio in London and the Canadian subsidiary of Korean pharmaceutical venture company Sumagen.

Chil-Yong Kang (pictured left), a professor is Western Ontario’s medical school, leads the research team developing the vaccine, designated SAV001. The vaccine uses a killed whole HIV-1 virus to stimulate an immune response, much like the vaccines for polio, influenza, rabies, and hepatitis A. The virus in this vaccine, however, is genetically engineered to be non-pathogenic and can be produced in large quantities.

In preclinical studies, SAV001 has shown to stimulate immune responses in preliminary toxicology tests with no adverse effects or safety risks.  The university says it is the only HIV vaccine currently under development in Canada.

The trials are expected to begin in January 2012, beginning with phase 1 study for safety on about 40 HIV-positive volunteers. Phase 2 trials will then measure immune responses in humans with some 600 HIV-negative volunteers believed to be at risk for HIV infection. Phase 3 clinical trials for efficacy will involve tests on about 6,000 HIV-negative volunteers also believed to be at risk for HIV infection.

Sumagen Canada and the university have a close working relationship. The company’s operations, established in 2008 manage and support clinical development of Kang’s vaccine, are located in Western Ontario’s research park. Sumagen Canada has secured patents in 70 countries for the vaccine, through the university’s technology transfer office.

Read more: FDA Approves HIV Drug in Combination Treatment

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