Experimental HIV Vaccine to Start Clinical Trials

MD Magazine® Staff

An experimental HIV vaccine using a killed whole virus and developed at the University of Western Ontario in Canada has received approval from the FDA to begin human clinical trials next month, the university has announced.

An experimental HIV vaccine using a killed whole virus and developed at the University of Western Ontario in Canada has received approval from the FDA to begin human clinical trials next month, the university has announced.

The vaccine, SAV001, has been under development for a decade by virologist Chil-Yong Kang, PhD, of the University of Western Ontario’s Schulich School of Medicine and Dentistry, and colleagues with the support of Sumagen Canada. According to the release, the vaccine has already demonstrated an ability to stimulate strong immune responses without causing adverse effects in preliminary toxicology tests.

Despite many attempts, no commercialized vaccine for HIV, the virus that causes AIDS, has been developed to date. Unlike other HIV vaccines that have been evaluated in human trials, SAV001 uses a killed whole HIV-1, like the killed whole viruses used in vaccines for polio, influenza, rabies, and hepatitis A. The killed virus in the vaccine has been genetically engineered to be non-pathogenic and to be replicable in large quantities.

Once inside the body, the virus “will act as immunogen and the human body will react to this immunogen and make antibodies and proper immune responses,” Kang explained in a video discussion of the vaccine. (You can watch the video below.)

The vaccine still has a long way to go before gaining approval. The Phase 1 trial, set to begin next month, will evaluate the vaccine’s safety in 40 HIV-positive participants; Phase 2 will gauge immune responses in approximately 600 HIV-negative participants at high risk of HIV infection; and Phase 3 will measure the efficacy of the vaccine in approximately 6,000 HIV-negative participants at high risk of infection.