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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update
FDA Allows Large-Scale Trial of AIDS Vaccine
King Jr., Ralph T.
June 3, 1998
Wall Street Journal (06/03/98) P. B1

The Food and Drug Administration has awarded VaxGen permission to launch phase III trials of its Aidsvax AIDS vaccine candidate. The trial, which will last at least three years, will involve 5,000 subjects in the United States and 2,500 in Thailand. Some researchers--including Dr. David Baltimore, president of the California Institute of Technology--are skeptical about the vaccine, although phase I and II trials indicate that it induced measurable HIV antibodies in over 90 percent of those who received it. The vaccine candidate is designed to fight the two most common strains of HIV in the United States. Researchers who doubt the effectiveness of the vaccine candidate claim that it does not cause enough of an immune response. VaxGen is run by virologist Dr. Donald Francis, who also helped develop the gp120 AIDS vaccine--which was denied funding by the government after small-scale tests-- at Genentech. Dr. Anthony Fauci, head of the National Institute for Allergy and Infectious Diseases, noted that the new trial information is "interesting" and said that "if they have the resources to do it, there's a possibility that something can be learned."