FDA Approves New HIV Vaccine For Clinical Trials

FDA  Approves New

HIV Vaccine For Clinical Trials

by Jared Skye

A vaccine for the HIV virus has long been the golden fleece of the infectious disease community, and has generally been considered the most likely way to permanently stop the disease from spreading. Most of these vaccine dreams fall through into a quagmire of regulatory oversight and  funding, but there has been renewed life breathed into this field recently, thanks to a Canadian research team being led by Dr. Chil-Yong Kang.

On December 20th of last year, the potential vaccine was approved by the FDA for Phase 1 human trials. This has cleared a path for involvement with American researchers on the project, and has also given the researchers a wider base of potential test subjects. Those Phase 1 trials have been set to begin this month, with a small group of HIV-positive subjects being given the vaccine. This first phase of human testing will be used to reinforce the safety of the vaccine before moving on to a larger base of subjects. The process will be a long, belabored one that is designed to show whether the vaccine is both safe and effective at protecting against HIV infection.

Video courtesy of The Huffington Post

Phase 2 will involve 600 HIV-negative subjects that live a lifestyle that gives them at a higher-than-normal possibility of contracting HIV. They will then move on to Phase 3, which will involve 6000 subjects and will be treated as the definitive measure of whether the vaccine is used. The process of creating vaccines is deliberately slow, with researchers making sure the vaccine is safe and effective before recommending its use.

The new vaccine operates in a way that is very similar to the way Jonas Salk’s polio vaccine works. It uses dead samples of the virus to create an immune-response in the body. Since HIV mutates quickly in the body, it is very difficult for the immune system to fight off the infection. However, if the body already has antibodies built up to help fend off the original virus, the HIV can be destroyed by the immune system before it has a chance to mutate. Since the virus is dead, it cannot infect the body, but it still causes the immune-response that triggers the creation of the antibodies.

This news has come on the heels of the miraculous story of Timothy Ray Brown, the HIV patient in San Francisco that was functionally cured of HIV earlier in 2011. Brown’s story, while ending with a positive result, is not indicative of a treatment that could be used to treat the more than 33 million HIV patients worldwide. His treatment involved an extremely intensive, expensive, and highly advanced set of bone-marrow transplants and stem cell transplants. This required many different donors, and is simply not a viable, worldwide solution to the HIV/AIDS epidemic.

It is important to note that a vaccine is far different from a cure. There are no studies that have found a viable way to eliminate HIV from the body after infection has taken place, aside from very costly and intensive procedures. This is due largely to the uncanny ability of HIV to mutate within its host very rapidly, making treatment for HIV very difficult. The vaccine could be the next best way to eliminate the virus, especially if made readily available to those that are most at risk for contracting the disease.


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One Response to FDA Approves New HIV Vaccine For Clinical Trials

  1. Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data (or more specifically, information about adverse drug reactions and adverse effects of other treatments) for health interventions (e.g., drugs, diagnostics, devices, therapy protocols). They are conducted only after satisfactory information has been gathered on the quality of the nonclinical safety, and health authority/ethics committee approval is granted in the country where approval of the drug or device is sought. ..;.`

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