An HIV vaccine developed at Western University is ready to move to the next stage of human clinical trials.
The SAV001 vaccine, developed by Dr. Chil-Yong Kang and his team at Western, could be tested in 600 HIV-negative subjects across North America as early as next fall, provided the Phase 2 trial gets the necessary approvals from government regulatory agencies.
The results of Phase 1, in which 33 HIV-positive volunteers were given the vaccine, showed SAV001 is capable of triggering an anti-HIV immune response in those who are HIV-positive. The trial also showed none of the subjects experienced an adverse events.
“We were very excited with the Phase I results,” said Kang. “The trial demonstrated that our vaccine stimulates broadly neutralizing antibodies that will neutralize 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.”
The next phase will see the vaccine given to 600 HIV-negative subjects. Of those, 300 will be volunteers from the general population and 300 will be from groups considered to be high risk. Those include men who have sex with men, intravenous drug users, sex workers, and those living with an HIV-positive partner.
“If we can show that this vaccine is effective in preventing people from contracting HIV, we can stop the AIDS epidemic and that would be tremendous,” said Kang. “It would be a tremendous contribution to humankind, and it would make all of our efforts worthwhile.”
Upon the successful conclusion of Phase 2, the trials will spread worldwide in Phase 3 with 6,000 subjects taking part.