DTHF to test the first African-developed HIV vaccine

May 2009 - DTHF’s Emavundleni Centre in Old Crossroads is one of three sites in the world to soon begin conducting Phase I human trials of the HIV vaccine produced in South Africa.

The trial, called SAAVI 102/HVTN 073, will be conducted jointly with the HIV Vaccine Trials Network (HVTN) and the US National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH). It will test two vaccines developed by the University of Cape Town through joint funding from South African AIDS Vaccine Initiative (SAAVI) and NIAID, NIH.

The development of these vaccines is the culmination of eight years of research and development which has involved scientists across South Africa and globally. The vaccine designs are based on HIV subtype C, the dominant strain circulating in southern Africa. They are the first HIV test vaccines developed in Africa to make it into human clinical trials.

This phase I trial commenced in Boston, USA in February 2009. Testing in South Africa will start in coming weeks. The trial has been approved by the South African Medicines Control Council (MCC) and the Directorate of Biosafety in the Department of Agriculture (which approves products using genetically modified organisms). The US arm of the trial will involve 12 participants whilst the South African arm aims to recruit 36 participants from two sites, Desmond Tutu HIV Foundation in the Western Cape and another in Gauteng.

DTHF has an established centre for vaccine research at Emavundleni in Old Crossroads. This centre has conducted several concurrent vaccine studies and is currently in the follow-up stage of two of these. This next trial will play an important role in this arm of our prevention research.

"This clinical trial represents a milestone for South Africa, as one of the few developing countries to have developed an HIV vaccine and progressed it into human clinical trials. It is progress in the search for an HIV vaccine which would provide the best chance to halt the global HIV epidemic; as well as a significant step in South Africa's growing competence in complex vaccine development," says Prof. Anthony MBewu, President of the Medical Research Council.

A phase I trial for an HIV vaccine generally involves volunteers who do not engage in risky sexual behaviours or intravenous drug use and are therefore at low risk for infection. A phase I trial primarily tests for safety, tolerability and side-effects but also starts to look at the effect of the vaccine on the human immune system. If successful, a phase I trial is followed by larger phase II and III trials which involve more volunteers and provide information on whether the product is able to protect against infection. A vaccine can only be licensed for public use after it has been tested and found successful in all three phases of clinical trials.

"SAAVI is extremely gratified that these test HIV vaccines are entering human clinical trials," says the Interim Director of SAAVI, Elise Levendal. "There is still a long way to go before we will know if these products will be in any way successful in preventing HIV infection. However, this important progress has been made possible by the excellent collaboration of the scientists, researchers and communities."