It’s a major milestone in the fight against HIV/AIDS, reached by one of Western’s own.
The first and only preventative HIV vaccine developed from a genetically modified killed whole virus by Western virologist Dr. Chil-Yong Kang and his Schulich School of Medicine & Dentistry team, has made significant progress with results from Phase I of human clinical trials showing no adverse effects so far.
“We are so excited about this interim report and are now proceeding with preparations for Phase II,” Kang said, after the public announcement Tuesday.
Patients in Phase I who received the vaccine saw no adverse reactions save the expected and understandable minor muscle and joint pain associated with all vaccines at the site of the injection, Kang explained. Their viral load did not increase and there were no reported abnormalities.
What’s more, Kang excitedly continued, is the preliminary results are showing promise for the effectiveness of the vaccine with observable growth of HIV-specific antibodies.
“If the vaccine works, you expect to see increased levels of antibodies, and the HIV-specific antibodies showed encouraging results. We were surprised to see (this),” he said, adding the results indicate the vaccine is safe and showing promise of effectiveness.
“We expect to get great news from volunteers in Phase II.”
Phase I of the human clinical trials for the vaccine (SAV001-H) began in March in the United States after receiving approval from the Food and Drug Administration (FDA). Testing the safety and tolerability of the vaccine, it was the first human clinical trial to use a killed whole virus.
FDA approval will be needed for Phase II and necessary materials still need to be developed, Kang added. He is confident things will go as planned and doesn’t see any challenges ahead.
Phase II will test for immune responses in healthy individuals and will take about a year. Phase III will test the efficacy of the vaccine and is expected to take at least three years. A marketable vaccine could be a possibility within five years, Kang said.
“If we can eradicate HIV, or if we can prevent HIV infection, certainly that will be the happiest achievement I can accomplish.”
The development of the vaccine was supported by Sumagen Canada. It is the only HIV vaccine currently under development in Canada, and one of only a few in the world.
Dr. Dong Joon Kim, a Sumagen Co. Ltd. spokesperson, echoed Kang’s excitement, calling the immune reaction observed in Phase I “amazing.”
“We found the virus 30 years ago, in 1983. During the 30 years, humankind and pharmaceutical companies have tried to develop a preventative HIV vaccine, but up until now, no one has,” he said. “Among those (vaccines) developing now, we can expect ours to prevent HIV/AIDS. We expect our killed whole virus vaccine will do that. We need it to be safe and it should succeed in producing immune response from human body.
“Today’s (announcement) is what we expected; it’s good news.”
Sumagen has, so far, invested roughly $60 million toward the vaccine. Kim expects another $30-40 million will be needed for Phase II and an additional $100 million for Phase III.
HIV/AIDS has killed more than 28 million people worldwide, and more than 34 million people currently live with the virus infection. Over the past three decades, there have been numerous trials through pharmaceutical companies and academic institutions around the world to develop vaccines, but one has yet to be commercialized.
Kang’s vaccine is unique in that it uses a killed whole HIV-1 virus. It is similar to killed whole virus vaccines for polio, influenza, rabies and hepatitis A. The HIV-1 is genetically engineered so it is safe and can be produced in large quantities.