by Mike Andrew -
SGN Staff Writer
An HIV vaccine being developed by Canadian researchers has passed its Phase I clinical trial, with no adverse effects reported in any of the patients involved in the study.
According to a statement released by Western University, based in London, Ontario, on September 3, the first successful test of the vaccine is especially significant because it is 'the first and only preventative HIV vaccine based on a genetically modified killed whole virus.'
Other HIV vaccines evaluated through human clinical trials have focused on either one specific component of HIV as an antigen, genetic vaccine using recombinant DNA, or recombinant viruses carrying the HIV genes.
The Canadian vaccine is unique in that it uses a killed whole HIV-1, much like the killed whole virus vaccines for polio, influenza, rabies, and hepatitis A. The HIV-1 is genetically engineered, so it is safer and can be produced in large quantities.
The vaccine was developed by Dr. Chil-Yong Kang and his team at Western's Schulich School of Medicine and Dentistry with the support of Sumagen Canada, a pharmaceutical company.
In its statement, the university said the vaccine 'holds tremendous promise for success in the final phases of clinical testing now that the first hurdle has been accomplished. It is the only HIV vaccine developed in Canada currently in clinical trial, and one of only a few in the world.'
The human clinical trial - a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine using intramuscular injections - began in March 2012 and was completed last month.
HIV-positive but asymptomatic men and women 18 to 50 years of age were randomized into two treatment groups, one of which received the vaccine and the other a placebo. Any adverse effects after vaccination were recorded on a diary card by the volunteers seven days after vaccination.
The volunteers visited the test sites on the fourth, sixth, 12th, 18th, 26th, and 52nd weeks after vaccination and were given hematology, clinical chemistry, and urinalysis tests, as well as physical examinations, by principal investigators. No serious adverse event was observed in any volunteer patient throughout the observation periods.
In addition to safety evaluation, tests to identify HIV-1-specific antibodies were conducted throughout the follow-up period and showed good results, researchers said.
'The boost in antibody production in HIV-positive volunteer vaccinees is highly encouraging,' the university's statement said, 'since it forecasts a success of the Phase II human clinical trial, which will measure the immune responses.'
SUMAGEN LOOKS AHEAD
Sumagen executives said the successful Phase I trial indicated they were on track to eventually produce the new vaccine for sale.
'We are now prepared to take the next steps towards Phase II and Phase III clinical trials. 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,' Sumagen CEO Jung-Gee Cho said.
HIV/AIDS has killed 35 million people worldwide, and more than 34 million people currently live with the virus.
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