Production problems and other issues will delay the largest planned AIDS vaccine trial by at least a year, Science has learned. The study--just the second efficacy trial ever for an AIDS vaccine--aims to test a pair of vaccines given in a one-two punch to some 16,000 participants in Thailand.
One source of the delay has been "routine production issues" in filling vials with the Aventis Pasteur vaccine, which is made by stitching HIV genes into a harmless canarypox virus, says Jim Tartaglia, who heads the effort for Aventis. The project also requires Thai officials to renovate 40 health centers, seven hospitals, and one clinic, notes Nusara Thaitawat of the Thai Ministry of Health, which is running the study. The test--expected to take at least 4 years to complete--also involves a research team from the U.S. Walter Reed Army Institute of Research and is largely funded by the U.S. National Institute of Allergy and Infectious Diseases.
Despite the delays, volunteer recruitment should start in September, Nusara says. And both Aventis and VaxGen, the other manufacturer, vow to have enough vaccine ready.