LONDON, ONT. - Canadian researchers have been given a green light to test a vaccine for HIV/AIDS on humans.
The approval from the Food and Drug Administration will lead to further tests that, if successful, could see a vaccine on the market in about five years, researchers from the University of Western Ontario said in announcing the milestone Tuesday morning at the campus in London. Ont.
The vaccine is the first based on a genetically modified, killed whole virus, following a line of research that successfully produced vaccines for polio, rabies and hepatitis A.
It is the only HIV vaccine currently under development in Canada, and one of only a few in the world, said the researchers.
Dr. Chil-Yong Kang and a team at the university, funded by pharmaceutical venture company Sumagen Canada, said approval by the American agency was crucial because its strict standards are generally regarded as a world standard.
A clinical trial on 40 HIV-positive volunteers will begin next month.
Those trials will be followed by tests on 6,600 HIV-negative but high-risk-category volunteers, testing immune responses and effectiveness of the vaccine in two more phases.
"I feel happy and comfortable with this human clinical trial," Kang told university and political leaders gathered for the announcement Tuesday.
Kang said the vaccine is being produced at special "bio-safety level 3" laboratories in Maryland and Colorado because there is no suitable lab in Canada.
Three earlier attempts at developing similar vaccines have failed since 2003.
Unlike other research, the Western team uses viruses it kills and genetically modifies to make them safe. Part of that process involves using white blood cells and the melittin protein from honeybees to help cultivate the vaccine.
Other attempts have used live viruses, because research found that route was successful in developing vaccines to combat mumps, measles and smallpox.
Kang said researchers in London had to conduct 230 different tests to satisfy the FDA, some involving primates, to ensure the vaccine would be safe to use on humans.
Sumagen Canada has secured patents to the vaccine in more than 70 countries.
HIV/AIDS has killed more than 28 million people worldwide, and more than 35 million people currently live with the virus that attacks the immune system. Since the virus was characterized in 1983, there have been numerous trials through pharmaceutical companies and academic institutions around the world to develop vaccines; however, no commercialized vaccine has been developed to date.
About the vaccine:
- Attempts to develop a vaccine in 2003, 2007 and 2009 failed.
- Western's is a new approach, similar to that used to develop vaccines for polio, influenza, rabies, hepatitis A, Japanese encephalitis for humans and 16 vaccines to prevent viral diseases in animals.
- The approach uses human immunodeficiency viruses that are killed, then genetically modified to be safe and cultivated with protein from honeybees.
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Originally Posted by Martin Luther King Jnr 
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