VaxGen May Pull Funding From Thai HIV Vaccine Trial Before Data Complete
Biotechnology company VaxGen has said that it may withdraw funding from a study of its AIDS vaccine that is currently underway in Thailand, which could lead to a "loss of invaluable data," Thailand's Nation reports. The Thai trial of the AIDSVAX vaccine has enrolled more than 2,500 volunteers, and VaxGen plans to announce results from the study later this year (Nation, 7/2). VaxGen in late February announced that AIDSVAX reduced the rate of new HIV infections by 3.8% among people who received the vaccine in another clinical trial, compared with participants who received a placebo injection. The company said at the time that the vaccine was effective among African Americans, Asians and other non-white, non-Hispanic volunteers. In a subgroup of 498 non-white, non-Hispanic volunteers, the vaccine appeared to provide protection in the range of 30% to 84%. However, further scientific analysis of the trial results showed "no stronger proof" of the company's original conclusion that the vaccine was more effective in African-American study subjects (Kaiser Daily HIV/AIDS Report, 4/1). VaxGen has not yet confirmed that it is pulling its funding of the Thai study, according to the Nation. Dr. Kajit Choopanya, principal investigator of the trial, said that the company is split between employees who want to pull out and scientists who say that the company must fund the study through its final analysis. According to the Nation, VaxGen is acting "entirely on commercial grounds" in making its decision. Several U.S. government agencies and the Bill & Melinda Gates Foundation could step in and provide funding to keep the trial running, the Nation reports.
'Far Reaching Effects'
Peggy Johnston, director of the vaccine and prevention research program at the National Institute of Allergy and Infectious Diseases, said that losing VaxGen's funding for the study could have "far reaching effects" (Nation, 7/2). She added, "Imagine going to a developing country again and asking them to roll up their sleeves for an efficacy trial if we didn't finish this one." Johnston said that VaxGen's board of directors has said they are "not interested" in finishing the trial. However, she added that the "staff, having put blood, sweat and tears into the trial, are very interested in completing it. We are in discussions now to decide what [VaxGen] will need to complete the trial." Johnston said, "From a scientific perspective, it would be a tremendous loss not to complete the trial and analyze the data" (Boseley, Guardian, 7/1). VaxGen insisted that it was not pulling out of the trial "but simply did not have the money to analyze all the data," the Nation reports. Lance Ignon, VaxGen's vice president of corporate communications, said, "The financial markets sent a loud and clear signal to us thorough the decline in our stock value and through conversations with members of the financial community. Their unambiguous response was, please do not spend more money than is necessary on your trials." Gregg Gonsalves, director of treatment and prevention advocacy at Gay Men's Health Crisis in New York, said, "Based on the poor results from their trial in the United States, I think they made a rational decision" to end funding for the Thai trial. "They've been hyping this vaccine for many years based on dubious data, but at some point, all the hype in the world can't salvage a product that doesn't work," he said. AIDSVAX is one of two vaccines set to be studied among 16,000 participants in another trial in Thailand scheduled to begin in October, the Nation reports (Nation, 7/2).