Phase I Trial of Italian HIV Vaccine Trial Successful, Researchers Say; Phase II to Test Vaccine in Africa

Italian researchers on Tuesday announced they have completed a Phase I trial of an HIV/AIDS vaccine, with all volunteers producing HIV-specific antibodies, Xinhuanet reports (Xinhuanet, 7/5). Barbara Ensoli, the lead researcher with the Istituto Superiore di Sanita, said, "The information we've gathered allows us to affirm that the vaccine is safe and well-tolerated in all subjects," adding, "We also had much better immunogenicity results than we expected, so we're going to move to Phase II ahead of schedule." Researchers began the trial in 2003, enrolling 47 volunteers at four clinics in Italy (Darlington, Reuters, 7/5). The volunteers -- 27 of them HIV-positive and 20 HIV-negative -- were given five vaccinations over five months. The Italian vaccine differs from other HIV/AIDS vaccines being tested worldwide because it targets TAT, a protein that allows HIV to replicate (Associated Press, 7/5). The researchers plan to conduct Phase II trials of the vaccine in Africa, but they said they need about $477 million to bring it to market by 2010 (Xinhuanet, 7/5). About 30 HIV vaccines are in clinical trials worldwide, but only a dozen have moved to Phase II, according to the AIDS Vaccine Advocacy Coalition (Reuters, 7/5).

Back to other news for July 7, 2005