The research team at Western University’s Schulich School of Medicine & Dentistry are planning to put their HIV vaccine (SAV001) into Phase II human clinical trials.
Developed by Chil-Yong Kang and a research team, the SAV001 vaccine uses a killed whole HIV-1, such as the killed whole virus used in vaccines for polio, hepatitis A, rabies, and the flu.
The killed HIV-1 has been genetically engineered to render it less dangerous and can be produced in large quantities.
The Phase II trial is planning to enrol 600 HIV-negative subjects across North America, out of whom 300 subjects will be considered among general population, and 300 from groups considered high-risk, including men who have sex with men, intravenous drug users, sex workers, and those living with an HIV-positive partner.
The trial will be intended to determine the efficacy of the vaccine in producing anti-HIV antibodies in patients who are not infected with the virus.
The previously held Phase I trial demonstrated the safety and efficacy of the vaccine in triggering an anti-HIV immune response in HIV-positive patients.
Kang said: “We were very excited with the Phase I results.
“The trial demonstrated that our vaccine stimulates broadly neutralising antibodies that will neutralise not only single sub-types of HIV, but other sub-types, which means that you can have the vaccine cover many different strains of the virus.”
Conditioned to the success of the Phase II trial, the university will conduct the Phase III trial among 6,000 people to reinstate the efficacy of the vaccine to protect people against HIV infection.
Image: Western University to test HIV vaccine in human. Photo: courtesy of Western University.
