An HIV vaccine (SAV001) can now move on to Phase II human clinical trials. Plans are underway to test it in 600 HIV-negative subjects across North America. The Phase II trial, once approved by regulatory agencies, will determine the vaccine’s ability to produce anti-HIV antibodies in patients who are not infected with HIV.
The results of the Phase I trial were published this week in the journal, Retrovirology, and showed that the vaccine is both safe for use and effective in triggering an anti-HIV immune response in HIV-positive patients. The results demonstrated that the vaccine was well tolerated with no serious adverse events and can now proceed to Phase II.
“We were very excited with the Phase I results,” said Kang, a professor in the Department of Microbiology & Immunology at Western. “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 SAV001 vaccine is unique in that it uses a killed whole HIV-1, much like the killed whole virus used in vaccines for polio, hepatitis A, rabies, and the flu. The killed HIV-1 is genetically engineered so it is less dangerous and can be produced in large quantities. The vaccine is the world’s first preventative HIV vaccine using genetically modified killed whole-virus to receive approval by the United States Food and Drug Administration (FDA) to proceed to this phase of human clinical trials.
“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.”