HIV/AIDS vaccine passes Phase 1 clinical trial in humans

Pharmaceutical company Sumagen Canada announced yesterday the successful completion of a Phase 1 Clinical Trial of SAV001-H, a vaccine against HIV and AIDS. The trial ran for over a year, from March 2012 through last month, and was designed to test the "safety, tolerability and immune responses" of the drug in real live human subjects. Phase 1 trials are the point at which researchers go from seeing whether their drugs work in animals to making sure that they don't do weird and bad stuff to people, so the stakes are obviously very high. SAV001-H passed flawlessly: in the randomized, observer-blinded, placebo-controlled study of HIV-infected, asymptomatic men and women, there were "no serious adverse event[s]," meaning that Phase 2 trials (seeing how well the vaccine actually works) can come next.

SAV001-H is what's called a "killed whole virus vaccine," meaning that it includes actual HIV viruses. This sounds like something that you don't want to get injected with, but as part of the vaccine-making process, the live HIV viruses are genetically re-engineered to eliminate pathogenicity, chemically treated, and then irradiated with gamma rays to make sure that they're dead dead dead. While other HIV/AIDS vaccines that haven't used killed whole viruses (relying instead on targeting specific components of HIV) have failed in Phase 3 trials, Sumagen is optimistic about their drug because other successful vaccines (including polio, influenza, rabies, and hepatitis A) work on the same principle.

The vaccine prevents HIV infection by massively boosting the production of a variety of antibodies in the human immune system. We won't get detailed statistics on how effective SAV001-H is until the completion of the Phase 2 trials, but even during Phase 1, the researchers were able measure boosts in the production of a variety HIV-specific antibodies ranging anywhere from eight to 64 times higher than with a placebo. Plus, these increases in antibodies were maintained over the entire duration of the study. Based on these data, Sumagen is "[forecasting] a success of the Phase 2 human clinical trial."

It would be premature to get too excited about this, since many vaccines encounter issues in Phase 2 and Phase 3 clinical trials. But, we're excited anyway. 35 million people have died of HIV/AIDS, and nearly as many are currently infected. 40% of new infections occur in people between the ages of 15 and 24. According to Sumagen, when this vaccine comes to market (and it's getting closer), it could mean "the eradication of HIV/AIDS for human beings." Eradication. Forever.

Sumagen, via UWO

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