An HIV vaccine (SAV001) developed at Western University can now move on to Phase II human clinical trials. Plans are underway to test it in 600 HIV-negative subjects across North America as early as next fall. The Phase II trial, once approved by government regulatory agencies, will determine the vaccine’s ability to produce anti-HIV antibodies in patients who are not infected with the virus.
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.
Developed by Chil-Yong Kang and a research team at Western’s Schulich School of Medicine & Dentistry, the vaccine was tested in 33 HIV-positive volunteers. The proposed next phase will involve 300 volunteers from the 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.
“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.”
HIV/AIDS has killed more than 41 million people worldwide, and more than 35 million people currently live with the infection.
“It remains to be determined whether this immune response triggered by the vaccine will prevent HIV infection in humans, but we are hopeful,” said Kang.
Once Phase II has been successfully completed, Phase III will be conducted world-wide with 6,000 subjects and will be the true test to show if the vaccine is effective in protecting people against HIV infection.
The vaccine is being tested in partnership with Sumagen Canada, the Canadian branch of Korean pharmaceutical venture company, Sumagen Co. Ltd. which has been producing the vaccine for clinical trials and holds the patent on the vaccine for mass production and distribution.
MEDIA CONTACT: Crystal Mackay, Media Relations Officer, Schulich School of Medicine & Dentistry, Western University, t. 519.661.2111 ext. 80387, c. 519.933.5944, email@example.com @CrystalMackay
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ABOUT THE SCHULICH SCHOOL OF MEDICINE & DENTISTRY
The Schulich School of Medicine & Dentistry at Western University is one of Canada’s preeminent medical and dental schools. Established in 1881, it was one of the founding schools of Western University and is known for being the birthplace of family medicine in Canada. For more than 130 years, the School has demonstrated a commitment to academic excellence and a passion for scientific discovery.
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