A Phase I clinical trial of the first and only preventative HIV vaccine based on a genetically modified killed whole virus has been hailed a success by researchers.
The vaccine, developed by University of Western Ontario with the support of Sumagen Canada, showed no adverse effects in all patients involved in the study.
Proving the vaccine, known as SA001-H, was safe for humans was a major hurdle for researchers to overcome in order to go forward with further development of the vaccine.
Sumagen CEO Jung-Gee said: "Even though Sumagen has struggled and spent a much longer time to overcome manufacturing difficulties and to meet the USFDA’s requirements, we have accomplished successfully Phase I Clinical Trial of SA001-H and proven that there is no safety concern of SAV001-H in human administration."
The vaccine is unique because it uses a killed whole HIV-1, similar to the killed whole virus vaccines for polio, influenza, rabies and hepatitis A, which his genetically engineered so it is safer and can be produced in large quantities.
Developed by Dr Chil-Yong Kang and his team at the University’s Schulich School of Medicine & Dentistry, the Phase I clinical trial was launched in March 2012 and completed in August 2013.
HIV-infected, asymptomatic men and women between the ages of 18-50 were randomised into two treatment groups and given either the killed whole HIV-1 vaccine or placebo.
Participants were then asked to record any effects on a volunteer diary card seven days after the vaccine was administered. The patients were then monitored for up to 52 weeks after first taking the vaccine with no serious adverse event observed in any volunteer.
During the first trial HIV-1, specific antibody detections were recorded and an increase in antibody titers were recorded and maintained for some antigens during the 52 week study period, which is encouraging for the second clinical trial.
Cho said the company was now preparing to take the next steps towards Phase II and Phase III clinical trials; it will also be encouraging pharmaceutical companies, government, and charity organisations to enter into collaboration with the company in order to be ‘one step closer to the first commercialised HIV vaccine’.
HIV/AIDS was first characterised in 1983. It has killed an estimated 35 million people worldwide and more than 34 million people currently live with the virus.
To date, despite numerous trials, no vaccine for the virus has been successfully developed.
Image: The Phase I clinical trial of the vaccine was launched in March 2012 and completed in August 2013. Photo: courtesy of C Goldsmith.
