Results From Thai HIV/AIDS Vaccine Trial Scheduled To Be Released In July

The Thai Ministry of Public Health on Tuesday announced that results from the latest phase of an HIV/AIDS vaccine clinical trial are scheduled to be released in July, Thai News Agency/MCOT reports (Thai News Agency/MCOT, 5/1). The NIH-funded trial is testing Brisbane, Calif.-based biotechnology company VaxGen's AIDS vaccine AIDSVAX in conjunction with Sanofi Pasteur's ALVAC among 16,000 HIV-negative volunteers from Thailand's Rayong and Chon Buri provinces. In the trial, AIDSVAX is used as a booster for the ALVAC vaccine. Each volunteer for the trial, which is scheduled to end in 2009, will be followed up for at least three-and-a-half years. Some researchers have questioned the validity, science, ethics and potential efficacy of the trial. A group of 22 prominent AIDS researchers in the Jan. 16, 2004, issue of the journal Science wrote that the study should be halted because of its high cost and because the two vaccines used by themselves in Phase I and Phase II clinical trials were ineffective in preventing HIV transmission (Kaiser Daily HIV/AIDS Report, 5/22/06).

According to Thawat Suntrajarn, director-general of Thailand's Department of Disease Control, the health ministry last week discussed the results with several U.S. government agencies and companies to prepare a response plan to handle any emergencies that arise after the results are released. NIH and the vaccine makers will meet in Thailand in June to determine the next steps in the process, Thawat said. If the test results find the vaccine has an efficacy of 80% or higher, the vaccine will enter commercial production. The vaccine will be tested for another two years if it is found to have an efficacy of between 50% and 79%, and the trial will be discontinued if the efficacy is below 50%, according to Thai News Agency/MCOT (Thai News Agency/MCOT, 5/1).

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