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Back to Section One | Back to Arts & Entertainment
posted Friday, December 23, 2011 - Volume 39 Issue 51
FDA approves HIV vaccine study
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FDA approves HIV vaccine study

by Mike Andrew - SGN Staff Writer

The FDA has approved human testing for a new HIV vaccine, SAV001. Approval was announced December 20.

Beginning in January, the vaccine will be administered to 40 healthy HIV-positive subjects to test its safety.

If SAV001 is proven to be safe, the vaccine will enter the second phase of clinical trials, in which it will be tested on 600 HIV-negative volunteers at high risk for HIV infection. Researchers will measure the volunteers' immune response to the vaccine.

The third and final phase would enroll 6,000 HIV-negative volunteers at high risk for HIV infection. Half the participants would be vaccinated and half would be left unvaccinated. They would then be tracked for three years to observe how many in each group become infected with HIV.

SAV001 was developed after 20 years of research at the University of Western Ontario in Canada.

Dr. Chil-Yong Kang, professor of virology at the Schulich School of Medicine and Dentistry at the University of Western Ontario, called the FDA approval a 'milestone.'

'We started the basic science research two decades ago,' Kang said. 'The vaccine development, we started 10 years ago. This is incredible for us to get to this stage of development.'

'We have gone through so many different challenges to come to this point,' he added.

'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.'

Kang said the vaccine is the first preventative HIV vaccine approved for clinical trials to use a killed whole HIV-1 virus to activate the immune response in humans.

The HIV used in the vaccine has been genetically altered to render it non-pathogenic, meaning it is unable to cause disease. Kang and his research team then further inactivated the virus using chemicals and radiation.

'In the past, people did not use this strategy because people did not know how to make a safer virus and people did not know how to make large quantities of it,' Kang said. 'Now we have solved those problems by the genetic engineering of the virus.'

The strategy has been used before to develop successful vaccines for influenza, polio, rabies, and hepatitis A. Kang said these past successes indicate the SAV001 vaccine will work against HIV.

According to the International AIDS Vaccine Initiative, there are 30 HIV vaccines currently being tested in phase 1 clinical trials around the world.

Many of these vaccines have largely focused on using one specific component of HIV to trigger an immune response. Other vaccines have used other viral vectors.

To date, no HIV vaccine has been proven effective.

Kang and his team received funding from Sumagen Canada, a subsidiary of a Korean-based pharmaceutical venture company created in 2008 to support the development of the vaccine.

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