HIV vaccine trial has been approved
A breakthrough in the medical world – a vaccine that may prevent HIV – has been given the go ahead for human clinical trials by the U.S. Food and Drug Administration, according to Canadian researchers at the University of Western Ontario in London, Ontario.
Dr. Chil-Yong Kang, a researcher and professor at Western’s Schulich School of Medicine and Dentistry made the announcement, saying “We have gone through so many different challenges to come to this point, this is the first time that I feel very happy and comfortable to initiate this human clinical trial. FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection.”
The vaccine, which is based on a genetically modified killed whole virus, was developed by scientists at UWO and financially backed by the pharmaceutical company Sumagen. It created a strong response in initial testing and appears to have no adverse affects.
There have been three clinical trials in the past for an HIV vaccine, but all three used live viruses. This will be the first vaccine to go through clinical trials using a killed virus.
The vaccine, known as SAV001, will have to go through three phases of human clinical trials.
This first trial will be in January 2012 and will retest the safety of the vaccine on 30 HIV-positive people.
The second phase will take 600 HIV-negative people at high risk for contracting the virus, and examine their immune system’s response to the vaccine.
The final phase will involve 6,000 HIV-negative high risk volunteers to determine the effectiveness of the vaccine.