Work on the Western-developed HIV/AIDS vaccine has cleared its latest hurdle with successful animal toxicology testing and opened the way for the human toxicology phase.
Yong Kang, a professor in the Schulich School of Medicine & Dentistry’s Department of Immunology & Microbiology, is thrilled to see his vaccine enter Phase 1 of human toxicology.
“Each step is exciting because it brings us one step closer,” says Kang, who has been working towards the HIV/AIDS vaccine for more than 20 years.
Sumagen Canada Inc. (a subsidiary of Curocom of Korea), to whom the vaccine is licensed, is expected to apply to the U.S. Food and Drug Administration for approval to begin toxicology tests on approximately 40 HIV positive individuals not yet symptomatic with AIDS.
Kang says the U.S.-based testing should get underway this fall, lasting less than a year. Should the vaccine be successful at this stage, Phase 2 of human toxicology would begin with a larger look at the immune response of the volunteers, expected to be approximately 600 people and lasting a little more than a year. If all goes well, Phase 3 would involve thousands of individuals.
Kang’s genetically engineered vaccine, produced in large quantities in a Maryland lab, uses what he calls a killed whole HIV-1. The idea is the vaccine would prime T-cells to destroy cells harboring HIV, essentially curing a patient of the virus.