AIDS vaccine Phase I trial successful
The 49 people who signed up to try out an AIDS vaccine appeared to be immune from HIV-1 and showed no adverse effects after 6 months. Phase I trials, of course, establish safety — it is up to the phase 2 trial to establish clinical efficacy.
"Forty-nine healthy people who received the injection showed no severe adverse reactions after 180 days, proving the vaccine was safe," said Zhang Wei, head of the pharmaceutical registration department of the SFDA.
"The recipients appeared immune to the HIV-1 virus 15 days after the injection, indicating the vaccine worked well in stimulating the body's immunity," he told the press conference.
Then, Phase III trials are usually double-blind, control studies. In the case of this vaccine, I don't see the Phase III trial happening exactly as it would with something like a new blood pressure or cholestrol medication. It would be unethical to expose individuals to the virus if they were only taking a placebo — especially if Phase II trials are also successful. Xinhua reports that the third phase will "will target the protection it offers for high-risk groups" — whatever that means.
The trial, which took place in China, was run by the National Institute for the Control of Pharmaceutical and Biological Products, and they're looking for about 300 at-risk volunteers for Phase 2 testing, and 500 more for Phase III testing.
The individuals in this test were paid $250 for their troubles, and were told they would not be infected by taking the vaccine, as it didn't contained the live virus.
I'll be watching these developments with interest.
[Image from the Duke Human Vaccine Institute]
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