Posted: October 20th, 2009 | By Claire Keeton | Posted in Phambili trial,vaccine | Tagged as , , ,

The long-awaited full results of the Thailand RV144 vaccine trial, presented at AIDS Vaccine 2009 in Paris this morning, yielded nothing unexpected.

The data and report, published in The New England Medical Journal today, confirmed what is already known: the vaccine had a modestly protective effect (31% efficacy compared to the placebo), was safe and well tolerated.

The trial investigators stood by their announcement last month that the effect was statistically significant – which has been a topic of much controversy in the last few weeks. One of their main points was that the statistics should be measured against the design of the trial and they explained why.

Colonel Nelson Michael, director of the US Military HIV Research Program, who presented along with Supachai Rerks-Ngarm, from the Thai Ministry of Health, Thailand, said: “This is the first evidence that a prime-boost HIV vaccine regimen may prevent infection and represents a significant step forward for vaccine research.

“While it will not likely have any immediate public health benefit, we are hopeful that the findings will guide additional studies and accelerate research efforts toward a more effective vaccine.”

Scientists at the plenary commented that the cellular immune results, released today, were what they had anticipated, and that important antibody tests had not yet been done so they could not comment on the vaccine’s ability to boost the humoral immunity (antibody immunity).

In summary, researchers still have no immunological clues as to why this vaccine was partially successful and this is one of the major questions that they will investigate now.

On the other hand, much of the data Dr Glenda Gray, director of the Wits Perinatal HIV Research Unit, presented from the interim analysis of the Phamibili study in South Africa (which was suspended in September in 2007 for showing no effect) was made public for the first time.

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