South Africa’s Medicines Control Council Approves Country’s First HIV Vaccine Trial
South Africa's Medicines Control Council has approved the country's first HIV vaccine trial, which is also the first trial of a vaccine targeting the C strain of the virus, the most prevalent strain in southern Africa, Reuters reports (Reuters, 6/19). The technology used in the vaccine, which is manufactured by Durham, N.C.-based biotechnology company AlphaVax, was initially 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, the Medical Research Council of South Africa and AlphaVax (Panafrican News Agency, 6/20). The AlphaVax vaccine uses a harmless form of the Venezuelan equine encephalitis virus to deliver portions of the C strain of HIV to the immune system (South African Press Association, 6/19). VEE is considered to be a particularly promising means of delivering HIV because it targets dendritic cells, which when infected with the virus travel directly to the lymph nodes and activate the killer T cells and antibodies needed to fight infections. The trials are slated to begin first in the United States and, pending a favorable safety review by the FDA and the MCC, the study will commence in South Africa several weeks later in order to avoid the impression that foreign scientists are "exploiting subjects" from developing nations for scientific gain, according to Xinhua News Agency. During the Phase I clinical trial, which tests the safety and dosage of the vaccine, 80 volunteers will receive the vaccine and 16 will receive a placebo (Xinhua News Agency, 6/19).
The vaccine will be administered to healthy, HIV-negative South African individuals, who will be monitored for one year at the perinatal HIV research unit at Chris Hani-Baragwanath Hospital in Soweto and the South African AIDS Vaccine Initiative Vaccine Research Unit at the Medical Research Council in Durban (SAAVI release, 6/19). The U.S. arm of the trials will be conducted at Johns Hopkins University, Columbia University, the University of Rochester and Vanderbilt University (AIDS Vaccine Advocacy Coalition release, 6/19). All of the testing sites are part of the HIV Vaccine Trials Network (SAAVI release, 6/19). The tests are being conducted in the two countries in order to determine how different people's immune systems react to the vaccine (Reuters Health, 6/19). Participants will receive detailed information about the vaccine as well as risk reduction counseling and clinical monitoring to encourage participants to avoid exposure to HIV (Mohapeloa, BuaNews/AllAfrica.com, 6/18). Principal researcher Dr. Glenda Grey said that the researchers would able to determine after two-and-a-half years whether the vaccine will move on to Phase II clinical trials, in which the vaccine's effectiveness would be determined. Overall, the vaccine would require an additional eight to 10 years before it would be ready for registration, Grey said, according to SAPA (South African Press Association, 6/19). The vaccine is one of three vaccines scheduled for human testing in South Africa and one of more than 20 vaccines entering human studies worldwide, according to South Africa's Star (Altenroxel, Star, 6/19).