A vaccine offering protection from the HIV virus, the cause of AIDS, has been approved by the U.S. Food and Drug Administration (FDA) for clinical trials in humans.
According to Dr. Chil-Yong Kang, a researcher and professor at The University of Western Ontario's Schulich School of Medicine and Dentistry, the vaccine (SAV001) is based on a genetically modified killed whole virus.
Kang said there have been a number of clinical trials for an HIV vaccine in the past but these all used live viruses. None used his team's approach, he said, referring to the use of a killed virus. Polio, influenza, rabies and hepatitis 'A' vaccines are also killed whole virus vaccines.
Getting FDA approval for the trials, beginning this January, is an "extremely significant milestone for our vaccine," Kang said.
The vaccine enters phase I of the human clinical trials this January to double check it's safety. All 40 volunteers in the first phase will be HIV-positive. The following two phases will involve HIV-negative volunteers who are all individuals at high risk of contracting the HIV virus.
Phase II will measure the immune response in humans using approximately 600 volunteers, while phase III will use approximately 6000 volunteers to rigorously test the effectiveness of the vaccine in preventing HIV infections.
According to information released by Western:
"HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the virus infection. 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."
The research was funded by Sumagen Canada, a pharmaceutical venture company, which has secured patents for the SAV001 vaccine in more than 70 countries, including the U.S., the European Union, China, India and South Korea. Sumagen Canada is a subsidiary of Sumagen Co. Ltd., Korea. The Canadian subsidiary was established in 2008 specifically to manage and support clinical development of Kang’s vaccine.