A Promising Trial
BY Michelle Garcia
February 16 2012 1:00 AM ET
While an estimated 30 HIV vaccines are being tested around the world, one trial in Canada promises to be unique. After decades of research, development, and high hopes, scientists at the University of Western Ontario are ready to test a new type of vaccine known as SAV001 that they hope will prevent HIV infections.
What makes this trial different, said lead researcher Chil-Yong Kang, Ph.D., is that this is the first preventive vaccine to use a 'killed whole' HIV-1 virus to activate a person's immune system. This version of the virus, however, would be genetically altered so it would not be able to cause HIV infection. For insurance, the virus is also inactivated by using chemicals and radiation.
Kang said this process has not been used before because it was unknown whether a safer version of the virus could be made in large quantities. However, a similar approach has been employed for polio, flu, hepatitis A, and rabies vaccines.
The first 40 people began vaccination trials to make sure SAV001 was not toxic. The next phase will occur among 600 HIV-negative people with have a high risk of infection. The last phase will be a three-year study of 6,000 volunteers, half of whom will receive a placebo.
Kang acknowledged that SAV001 is not particularly helpful for people with HIV, so the next venture for his team is to develop a therapeutic vaccine for those already living with it. Because HIV is a persistent virus that even affects one's DNA when introduced to the body, it is notoriously difficult to eradicate. For people with HIV who have not developed AIDS, a therapeutic vaccine would 'hopefully educate our white blood cells so they can destroy and clear the viral infection,' he said.
After two years of evaluation, SAV001 has won approval from the U.S. Food and Drug Administration. This will allow the research team to recruit American volunteers for the vaccine. The FDA is known for having the most stringent approval requirements for such vaccination trials.
'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,' Kang said in a statement.