HIV Vaccine Approved By FDA for Human Trials

The FDA has approved a Phase 1 clinical trial for a new promising vaccine. The drug was developed by a team of Canadian researchers led by Dr. Chil-Yong Kang. It may prevent the transmission of HIV, saving millions of lives around the world.

In order for a drug to be placed on the market it must go through a number of trials, first in animals and then in humans, to test safety and efficacy. Phase 1 will include 40 HIV-positive participants and will test the safety of the vaccine, called SAV001.

According to Dr. Kang, it may be up to five years before the vaccine is placed on the market. It will take about 6 months for the first phase to be completed and a year to analyze and interpret the results. Phase 2 will measure the immune system's response of 600 HIV-negative people that are at high risk for HIV infection. These include sex workers, people in the gay community with multiple partners, hemophiliacs and i.v. drug users. Phase 3 will include 6,000 HIV-negative people that are high risk. It will test how effective the drug is by comparing the vaccinated group to a non-vaccinated group.

The vaccine is similar to Salk’s Polio vaccine and the vaccine for Hepatitis A. It contains dead HIV-1 virus. By giving humans the dead virus or immunogen, the body will react and build immunity. This immunity will protect the individual from becoming infected during any future encounter with the live virus.

According to CBC News, there have been three clinical trials for and HIV vaccine in the past using live virus. However, none of the researchers in those trials used Dr. Kang's idea of using killed virus.

In 2009, there were about 33 million people living with HIV/AIDS. Over half of them were women. A majority of those living with the disease are in sub-Saharan Africa, including 2.3 million children. In addition, 90 percent, of the children orphaned because of AIDS are in sub-Saharan.

The implications for this vaccine are staggering. Researchers must wait until the end of the Phase 3 trials before they can determine whether the vaccine will be effective. Kang is also working on a treatment for those who are already HIV-positive.

Source: avert.org, www.cbc.ca, www.edmontonjournal.com
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