FDA Clears HIV Vaccine For Human Trials

DETROIT (WWJ) – An Ontario doctor is hopeful that a vaccine he developed can stop the transmission of HIV — the virus that causes AIDS.

University of Western Ontario researcher Dr. Chil-Yong Kang said his treatment is the only one to use a “whole” genetically modified HIV virus that’s been killed, much like methods used for polio, rabies and flu vaccines.

“We started our research on HIV and AIDS 20 years ago and over the last 10 years we have developed a vaccine. The vaccine is a prophylactic vaccine which is a preventative vaccine,” said Kang.

So far, the vaccine has only been tested in monkeys, but the treatment has given doctors reason to be cautiously optimistic.  The U.S. Food and Drug Administration has cleared the vaccine for human trials, a process which will take about five years.

“We need about 6,000 people to test to have statistically significant data, so we can compare a vaccinated and non-vaccinated group to see how effective this vaccine is for prevention of HIV infection,” said Kang.

The first phase of trials lasts about one year and involves a group of 40 volunteers to ensure the vaccine is  safe. The next phase lasts another year and involves about 600 volunteers in the high-risk  categories for contracting HIV. The final phase involves 6,000 people in high-risk  categories.

Kang said volunteers will not receive the live HIV virus,  but will be injected with the vaccine. Then, researchers will monitor their immune responses and wait for a natural infection.

According to estimates from the UNAIDS Global Report 2010, around 30.8 million adults and 2.5 million children were living with HIV at the end of 2009.


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