HIV Vaccinations in Trial Discontinued, Study Will Continue, Project Director Says

Joseph Makhema, project director at the Botswana-Harvard School of Public Health AIDS Initiative Partnership for HIV Research and Education, on Thursday announced that vaccinations in the Phase I HIV vaccine trial of AVX101 have been discontinued, AllAfrica.com reports (Chwaane, AllAfrica.com, 5/5). South Africa's Medicines Control Council in June 2003 approved the AVX101 trial, which included 48 participants, with 24 in South Africa and 24 in the U.S. The first 12 participants in the U.S. were inoculated in July 2003. The technology used in the vaccine initially was developed by researchers at the University of North Carolina-Chapel Hill and the U.S. Army Medical Research Institute of Infectious Diseases and was applied to HIV by a team of researchers from the University of Cape Town in South Africa, the South African Medical Research Council and AlphaVax. The vaccine uses a disarmed virus to deliver synthetically produced pieces of HIV in order to stimulate an immune response. The vaccine cannot cause HIV infection in recipients (Kaiser Daily HIV/AIDS Report, 11/4/03). Makhema said the discontinuation of the vaccinations was because of "documentation irregularities" related to a warning letter issued by FDA regarding issues that the maker of AVX101 had with a product unrelated to the study vaccine, AllAfrica.com reports. He added the study will continue, the product was safe and study participants were not harmed (AllAfrica.com, 5/5).