The world may be one step closer to a preventative HIV vaccine as a result of research being spearheaded by Dr. Chil-Yong Kang and his team at Western’s Schulich School of Medicine & Dentistry, in conjunction with Sumagen Canada Inc.
Sumagen and Western University announced today that the Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed with no adverse effects in all patients. Additionally, antibody production was also boosted after the vaccination.
The vaccine (SAV001-H) holds promise for success in the final phases of clinical testing now that the first hurdle has been overcome.
Jung-Gee Cho, the CEO of Sumagen Co. Ltd., said even though Sumagen has struggled and spent a much longer time to overcome manufacturing difficulties, and to meet the strict requirements of U.S. FDA, officials have successfully accomplished Phase I Clinical Trial of SA001-H and proven there is no safety concern of SAV001-H in humans.
“We are now prepared to take the next steps towards Phase II and Phase III clinical trials,” Cho said. “We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine.”
It is the only HIV vaccine developed in Canada currently in clinical trial, and one of only a few in the world. The vaccine is the first genetically modified killed whole virus vaccine currently in human clinical trial to evaluate its safety, tolerability and immune responses.
The human clinical trial was initiated in March 2012 and completed in August 2013. HIV-infected, asymptomatic men and women, ages 18 to 50 years, were enrolled in the study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or a placebo.
The volunteers were to record any and all adverse effects after vaccination in a volunteer diary card seven days after administration. The volunteers visited the test sites on Weeks 4, 6, 12, 18, 26 and 52 after vaccination and were analyzed via hematology, clinical chemistry, urinalysis and physical examination by principal investigators. No serious adverse event was observed in any volunteers throughout the observation periods.
With encouraging results from the Phase I Clinical Trial, Sumagen is confident in developing SAV001-H as the first preventative HIV vaccine for saving millions of lives and is now preparing for the next phases of trials to show the resistance and effectiveness.
Sumagen has lofty hopes. Not only having the first HIV vaccine on the market, but also eradicating HIV/AIDS in human beings.
HIV/AIDS has killed 35 million people worldwide, and more than 34 million people currently live with the virus infection.