By Jon Cohen
A large clinical trial of an AIDS vaccine has, for the first time, yielded positive results. But researchers immediately questioned the relevance of the data, which indicated that the vaccine offered only modest protection against infection by HIV.
The controversial trial, conducted with more than 16,000 volunteers in Thailand over the past 6 years, tested the effectiveness of two AIDS vaccines used together as a one-two punch. Researchers randomly assigned an equal number of participants who were at average risk of becoming infected by HIV to receive either the two vaccines or a saline placebo. At the end of the study in June, 51 of the vaccinated people had become infected within 3 years of receiving their last shot, compared with 74 people in the placebo group. The p value, which indicates whether results are due to chance, was less than 0.039, just below the widely accepted but arbitrary “significance” cutoff of 0.05. Surprisingly, the vaccine did not appear to suppress levels of the virus in the 51 people who became infected. No serious adverse events were seen in either group.
Many AIDS vaccine researchers had predicted that the study would fail, and its sponsors are thrilled by the efficacy, marginal though it may be. “Although the level of protection was modest, we think the study is a major scientific advance,” said Colonel Jerome Kim, HIV vaccines product manager for the U.S. Army, which collaborated with the Thai Ministry of Health to conduct the efficacy trial. “We were all pretty energized by the results.” The U.S. military and Thai officials will announce the results of the trial, the largest ever held of an AIDS vaccine (see table on other AIDS vaccine trials after the jump), at press conferences today in Thailand and the United States.
Several longtime critics of the study, which cost $105 million, were dumbfounded—and circumspect—when they learned the results.
