Phase III Trial of Italian HIV Vaccine to Begin in October
Italian researchers announced on Wednesday that Phase III testing of an HIV vaccine is scheduled to begin in October and results could be available in two years, Reuters Health reports. The vaccine uses TAT toxoid, a benign form of a protein found in HIV, to initiate an immune response that "controls" HIV replication. The vaccine, which may be able to prevent and treat HIV infection, was determined to be safe, well-tolerated and effective in stimulating an immune response in people who participated in Phase I and II trials, which began in 1997. The Phase III trial will involve 120 HIV-positive individuals and 40 HIV-negative individuals. As in previous trials, participants will receive weekly injections of the potential vaccine and will be monitored for one year by the researchers, according to Dr. Pier Mannucci, director of the Hemophilia and Thrombosis Center at the University of Milan. "So far the results are very encouraging. We can claim that all patients enrolled in the trials are in good condition," Mannucci said, adding that the vaccine can be used in conjunction with antiretroviral therapy. Currently, although "[d]ozens" of potential HIV vaccines are being tested, only one other HIV vaccine -- VaxGen's AIDSVAX -- is in Phase III trials, the final stage of testing before a drug company can apply for FDA approval (Lorenzi, Reuters Health, 8/1).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.