Phase I of HIV Prevention Vaccine Clinical Trials Looks Promising
November 7, 2012 8:05 PM
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Over the course of Phase I, patients have not experienced negative effects while taking SAV001-H
for prevention has had a successful Phase I Clinical Trials in the United States, and is preparing to move on to Phase II and Phase III.
The preventative HIV vaccine (called SAV001-H) was developed by Dr. Chil-Yong Kang and a team of researchers at the University of Western Ontario's Schulich School of Medicine & Dentistry as well as researchers from Sumagen Co. Ltd. Unlike other HIV vaccines that underwent clinical trials, SAV001-H contains a killed whole HIV-1 rather than just one specific part of HIV as an antigen or genetic vaccine using recombinant DNA.
Phase I of clinical trials for the first HIV preventative vaccine started in March 2012.
Infected men and women
ranging from 18-50 years of age were separated into two groups, where one received SAV001-H and the other a placebo.
Over the course of Phase I, patients have not experienced negative effects while taking SAV001-H. This includes signs/symptoms, laboratory toxicities and local reactions.
"We have proven that there is no safety concern of SAV001-H in human administration and we are now prepared to take the next steps towards Phase II and Phase III clinical trials," said Dr. Dong Joon Kim, spokesperson for Sumagen. "We are delighted to be one step closer to the first commercialized HIV vaccine."
Also, interim data showed a large increase in HIV-1 antibody formations after SAV001-H was given to patients.
The humoral immune responses still need to be analyzed, but these initial results are promising. This could make SAV001-H the first commercially available HIV prevention vaccine in the United States at some point.
There has been great progress for preventative HIV drugs in the U.S. lately. Back in July, the U.S. Food and Drug Administration (FDA) approved the
HIV prevention pill called "Truvada."
University of Western Ontario
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11/7/2012 10:21:29 PM
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