The National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) awarded Sumagen Canada Inc. $728,000 to support human clinical trials for a preventative HIV vaccine, SAV001. Developed by Dr. Chil-Yong Kang and his team at The University of Western Ontario, the vaccine received approval in December from the United States Food and Drug Administration (USFDA) to start human clinical trials this month.
With the support of Sumagen Canada, and based on a genetically modified killed whole virus, the vaccine holds tremendous promise, having already proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or safety risks.
With the USFDA holding the most stringent approval requirements, Kang chose to go this route with the only HIV vaccine currently under development in Canada – and one of only a few in the world.
This financial assistance from NRC-IRAP and the Bill and Melinda Gates Foundation allows the team to proceed more quickly to Phase I human clinical trials to test the safety of SAV001.
HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the virus.
Since the virus was characterized in 1983, there have been numerous trials through pharmaceutical companies and academic institutions around the world to develop vaccines; however, no commercialized vaccine has been developed to date. Other HIV vaccines evaluated through human clinical trials have focused on either one specific component of HIV as an antigen, genetic vaccine using recombinant DNA, or recombinant viruses carrying the HIV genes. SAV001 HIV vaccine is unique in that it uses a killed whole HIV-1, a genetically engineered vaccine.