A team of researchers working out of the University of Western Ontario in London, Ontario, have received approval from the U.S. Food and Drug Administration to begin clinical trials of an HIV vaccine on humans beginning in January. What makes this vaccine different from the handful of others in development around the world is that it uses dead HIV-1 virus, in a similar methodology that led to vaccines for polio, rabies and hepatitis A.
The virus is first produced at special “bio-safety level 3” laboratories in Maryland and Colorado. It’s then killed and genetically modified to become harmless, and a protein found in honeybee venom cultivates it into the vaccine, which they’ve named SAV001. This is the fourth attempt to produce such a vaccine, and only passed FDA approval — considered the world gold standard — after it passed 230 different safety tests.
So now what? The clinical trials will take place in the U.S., where facilities are already set up. Phase 1 will take six months to complete and another year to evaluate the results. Phase 2 will measure immune-system response, and will involve 600 HIV-negative people in high-risk categories (hemophiliacs, IV drug users, sex trade workers and gay men with multiple partners). Phase 3 will expand to 6,000 HIV-negative people in high-risk categories, and compare vaccinated to a non-vaccinated control group. Until that phase is complete, it won’t be known for sure if the vaccine is 100% effective. If it is, then the vaccine will be ready to distribute in as little as five years. It will likely require two shots, given one month apart, as that’s what has produced antibodies in test animals.
Fingers crossed. And no matter what, don’t stop using condoms — you never know what’s lurking around the corner. Gwyneth Paltrow might have just shaken hands with a pig. [Montreal Gazette, Toronto Sun, Photo via Shutterstock]