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Leading AIDS experts criticize US-sponsored HIV vaccine trial in Thailand

Case Western Reserve University

In the Jan. 16 issue of the journal Science, several national AIDS experts criticize a U.S. government-sponsored clinical research trial of an AIDS vaccine in Thailand. The 22 researchers, including Michael Lederman, M.D., professor of medicine at the Case Western Reserve University School of Medicine and director of the AIDS Clinical Trials Unit at University Hospitals of Cleveland, say that there is no "persuasive data" to suggest that the experimental vaccine, a combination of ALVAC +gp120, would help to protect against HIV infection. The research trial involves16,000 volunteers in Thailand.

The scientists say that a clinical trial of similar design was scheduled to be conducted in the United States by the HIV Vaccine Trials Network (HVTN), the world's largest consortium of AIDS vaccine scientists and clinicians, but was cancelled last year because earlier trials had yielded weak results in terms of immune response to the vaccines.

Vaccines work by inoculating people with a small amount of a virus or portion of a virus to produce an immune response. The vaccine primes the body to recognize and fight the infection should the person be exposed to it in the future.

The Thailand clinical trial seeks to test the effectiveness of a vaccine made from a protein found on the surface of the AIDS virus, called gp120, when given in combination with ALVAC, a vaccine composed of a harmless canarypox virus that carries several genes from HIV. The Thailand trial is a Phase III trial which is designed to see if the combination of vaccines will prevent HIV infection or decrease the severity of the disease. The cost of the trial in Thailand is reported to be $119 million, according to the paper in Science.

The researchers who are critical of the trial praise the National Institutes of Health's investment in basic and applied immunology research during the past 15 years and write that the "cumulative expertise gained should be used when important strategic decisions are made." They say that the overall approval process lacked input from independent immunologists and virologists who could have judged whether the trial was scientifically meritorious.

"The scientific community must do a better job of bringing truly promising vaccine candidates to this stage of development," said Lederman, "otherwise we risk eroding public confidence in the research."

The authors of the paper are from many of the leading medical schools and research institutions in the nation, including Case, Harvard, Cornell, University of Pennsylvania, Northwestern, and UCLA.


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