Developed by Dr. Chil-Yong Kang and his team at Western's Schulich School of Medicine & Dentistry, with the support of Sumagen Canada, the vaccine (SAV001-H) holds tremendous promise for success in the final phases of clinical testing now that the first hurdle has been accomplished. It is the only HIV vaccine developed in Canada currently in clinical trial, and one of only a few in the world. This vaccine is the first genetically modified killed whole virus vaccine (SAV001-H) in human clinical trial to evaluate its safety, tolerability and immune responses. The human clinical trial was initiated in March 2012 and completed in August 2013. This trial was a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. HIV-infected, asymptomatic men and women, 18 to 50 years of age, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo.
The adverse effects after vaccination were recorded on a volunteer diary card by the volunteers seven days after vaccination. Thereafter, the volunteers visited the test sites on Weeks 4, 6, 12, 18, 26 and 52 after vaccination and were analyzed for hematology, clinical chemistry, urinalysis and physical examination by principal investigators. No serious adverse event was observed in any volunteer vaccinees throughout the observation periods.