A group of 22 prominent U.S. AIDS researchers this week called into question whether a $119 million HIV vaccine study launched in Thailand is worth the money--or even if the vaccine combination being studied could ever be effective, the San Francisco Chronicle reports. The study, which began in September and includes 16,000 volunteers, is evaluating the combined use of VaxGen's AIDSVAX with Aventis-Pasteur's ALVAC in preventing HIV infection. But two previous Phase III trials of AIDSVAX showed the vaccine had little effect in preventing infection, and early tests of ALVAC were similarly disappointing, according to the researchers.
The scientists, writing in the January 16 edition of the journal Science, express their doubts that combining the two ineffective vaccines will result in a viable product. "We seriously question whether it is sensible to conduct a third trial that, in our opinion, is no more likely to generate a meaningful level of protection against infection or disease," they wrote. "One price for repeated failure could be crucial erosion of confidence by the public and politicians in our capability of developing an effective AIDS vaccine."
Among the researchers to question the study are Dennis Burton of the Scripps Research Institute; Ronald Desrosiers of Harvard Medical School; Douglas Richman of the University of California, San Diego; Mike McCune of the Gladstone Institute for Virology and Immunology; and HIV codiscoverer Robert Gallo of Baltimore's Institute for Human Virology.
Officials at the National Institutes of Health, which is partially funding the study, said in a statement that they "strongly disagree with the authors' opinion." They also said the agency would draft a formal rebuttal to be published in an upcoming edition of Science. "Given the urgency of the situation, we are going with the 'bird in hand,' " said Peggy Johnston, director of vaccine research at the NIH. "We will learn something on this trial, even if it is found to be ineffective."