Canadian researchers recently received approval from the US Food and Drug Administration (FDA) to commence testing an HIV vaccine on humans.
The team of researchers, led by Dr. Chil-Yong Kang are working out of University of Western Ontario, and human testing will begin in January. Phase one of the testing will take six months, and will treat 40 HIV-positive patients. This phase will test the safety of the vaccine and it will take up to a year to evaluate the results.
The vaccine is the only one of its kind under development in Canada and uses the dead HIV-1 virus, which has been genetically modified to be non-pathogenic, meaning it won’t infect recipients. The methodology is similar to vaccines used against polio, rabies, influenza and hepatitis A and as Kang explains in the video:
We infect the cells with a virus and then the infected cells will produce lots of virus and we can collect them, purify them and then inactivate them,
The vaccine is the fourth attempt of its kind (with previous efforts failing in 2003, 2007 and 2009) and had to undergo 230 tests before receiving the stamp of approval from the FDA. FDA approval is regarded as the most stringent in the world. Getting a nod from the US health body makes the treatment viable across the globe.
While Phase one is underway, researchers will begin preparations for Phase two of testing, which will measure the immune response to the disease on 600 HIV-negative patients who are in high-risk categories for infection.
Four groups of people make up the high-risk category, including hemophiliacs, injection drug users, sex trade workers and those in the gay community with multiple sexual partners.
The third and final phase will require 6 000 HIV-negative people, also in high-risk categories and will test the vaccine’s effectiveness.
As it stands the vaccine, SAV 001, is administered via an injection, and it may take as little as two shots one month apart to produce sufficient antibodies, as was proven through animal testing. If successful, the vaccine may be distributed within five years.
[Source: Montreal Gazette, Toronto Sun]
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