Researchers To Begin First Human Clinical Trial of HIV Vaccine in South Africa
Researchers in South Africa this week are set to begin the country's first human trial of an HIV vaccine, the AP/San Francisco Chronicle reports (Zavis, AP/San Francisco Chronicle, 11/3). The South African AIDS Vaccine Initiative on Monday announced that the first South African inoculations for the Phase I clinical trial of the AlphaVax replicon Vector clade C candidate HIV-1 vaccine would take place this week, according to the South African Press Association. Phase I trials are aimed at determining the safety of the vaccine (South African Press Association, 11/3). South Africa's Medicines Control Council in June approved the trial of the vaccine candidate, known as AVX101. The technology used in the vaccine 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. 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, 8/27).
The trial -- which in South Africa will take place at the Chris Hani Baragwanath Hospital in Soweto and the SAAVI HIV vaccine research unit in Durban -- will include a total of 48 participants, with 24 in South Africa and 24 in the United States, South Africa's Star reports (Ancer, Star, 11/4). The first 12 participants in the United States were inoculated in July, according to the South African Press Association. The U.S. arm of the trial is taking place at Johns Hopkins University, Columbia University, the University of Rochester and Vanderbilt University (South African Press Association, 11/3). The trial is expected to last two years, according to the AP/Chronicle (AP/San Francisco Chronicle, 11/3). Dr. Glenda Gray, South Africa's national principal investigator of the HIV Vaccine Trials Network, said that the entire trial process for the vaccine would take up to 10 years to complete, according to the South African Press Association (South African Press Association, 11/3). The HVTN, which is funded and supported by NIH's National Institute of Allergy and Infectious Diseases, is conducting the trial (SAAVI release, 11/3).
A second trial involving another MCC-approved vaccine candidate is expected to begin in the "next few weeks," according to the Star (Star, 11/4). The second vaccine, named HIVA.MVA, 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. A phase I trial of the vaccine is also underway in Uganda. 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. Researchers will recruit a total of about 50 volunteers for the phase I trial of the vaccine candidate to test the safety of different methods of injecting the vaccine (Kaiser Daily HIV/AIDS Report, 8/27).
Tim Tucker, head of SAAVI, said, "An HIV vaccine is our best hope of eradicating HIV from the globe. It is an extremely exciting time" (AP/San Francisco Chronicle, 11/3). Tucker said that he "personally briefed" South African Health Minister Manto Tshabalala-Msimang, who offered support for the trial, as did Science and Technology Minister Ben Ngubane. Tucker added that the trials have been set up to ensure that the "ills of the past are not repeated" (South African Press Association, 11/3). SAAVI Deputy Director Dr. Ashraaf Grimwood said, "This is a really good time for South Africa -- once we have the rollout of [antiretroviral treatment], we will be able to see the limitations of treatment and see the need to continue pushing for the development of other strategies." He also said that although it may take several years to develop a vaccine, the clinical trial process in South Africa "has meant greater scientific infrastructure and participation for our communities," adding, "We are not only educating about vaccines, but raising general awareness about AIDS." Gray said, "This is the beginning of a long process. We are in kindergarten now -- we want to get to university" (U.N. IRIN/PlusNews, 11/3). IAVI President and CEO Seth Berkley said, "This marks one of the great moments in the global effort to stop the spread of the HIV/AIDS epidemic by developing a preventive vaccine," adding, "By testing multiple AIDS vaccine candidates at once ... South Africa will help speed the time to success." Berkley also said, "[W]e need commitment at every level to make a vaccine a reality" (IAVI release, 11/3).