South Africa’s Medicines Control Council Approves Country’s Second HIV Vaccine Clinical Trial
South Africa's Medicines Control Council has approved the country's second HIV vaccine clinical trial, which is expected to begin at the end of September, SAPA/Business Day reports (SAPA/Business Day, 8/26). Researchers will recruit about 50 volunteers for the phase I trial of the vaccine candidate, named HIVA.MVA, in order to test the safety of different methods of injecting the vaccine. The vaccine has already completed phase I trials in Britain and Kenya and is currently undergoing phase II trials -- which test the safety and effectiveness of the vaccine -- in those two countries (Altenroxel, Star, 8/26). A phase I trial of the vaccine is also underway in Uganda (SAPA/Business Day, 8/26). The vaccine was developed by scientists from the U.K. Medical Research Council's Human Immunology Unit at the University of Oxford and Kenya's University of Nairobi, with funding from the International AIDS Vaccine Initiative (Kaiser Daily HIV/AIDS Report, 5/21). The MCC in June approved South Africa's first HIV vaccine trial of the vaccine candidate AVX101. The technology used in that 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 (Kaiser Daily HIV/AIDS Report, 6/20). The two vaccine trials are separate but will run concurrently, according to South Africa's Star. Both vaccines use disarmed viruses to deliver synthetically produced pieces of HIV in order to stimulate an immune response. The vaccines cannot cause HIV infection in recipients.
Speeding Up the Process
"By studying different vaccine design strategies at once, rather than one at a time, South Africa will help to reduce the time needed to identify which is the most effective," IAVI President and CEO Dr. Seth Berkley said, adding, "In the search for an AIDS vaccine, speed is of the essence." The two vaccines are some of more than 20 that are currently in human clinical trials or waiting to enter human trials, according to the Star (Star, 8/26). IAVI's HIVA.MVA vaccine candidate is based on HIV-1 subtype A, which is common in east Africa, and AlphaVax's AVX101 is based on HIV-1 subtype C, which is most common in South Africa. "Ideally, a single AIDS vaccine will be highly effective against all subtypes of HIV," Dr. Wayne Koff, IAVI's senior vice president for research and development, said. He added, "Preliminary indications are that both of the vaccine candidates currently approved for testing in South Africa hold promise for meeting this goal, but only human trials will tell us for sure" (SAPA/Business Day, 8/26). Dr. Tim Tucker, executive director of the South African AIDS Vaccine Initiative, which coordinates AIDS vaccine research in South Africa, said, "What is happening in South Africa should be a model for the world. Local scientists are working in collaboration with international partners to streamline the process of discovering a preventive AIDS vaccine" (IAVI release, 8/25).