News release
24 January 2008

Fact sheet on the HVTN 073/ SAAVI 102 HIV vaccine trial

Two locally developed test HIV vaccines are nearing phase I clinical trials in humans. The vaccines, developed by research teams led by the University of Cape Town will be tested in both South Africa and the USA.

The test vaccines – called SAAVI MVA-C and SAAVI DNA-2 – have undergone laboratory and animal testing, and will now enter early phase human clinical trials. The DNA vaccine was wholly developed by South Africans - a team of scientists at the University of Cape Town’s Institute for infectious Diseases and Molecular Medicine. The MVA vaccine was conceptualised by the team at the University of Cape Town and developed and manufactured with input from international biotech company, Therion, and the United States National Institutes of Health (NIH).  The vaccines have been in development since 2002 and the project has been funded by the South African AIDS Vaccine Initiative and the NIH. Both vaccines were manufactured in the USA. The vaccines are specifically targeted at the HIV-1 strain C that accounts for the majority of infections in southern Africa.

The trial is a phase I trial involving 36 people at two sites in South Africa – one in Cape Town and one in Gauteng - and 12 people in the USA.

The trial has already been approved by the United States Food and Drug Administration and has been submitted for approval to the Medicines Control Council in South Africa.  It is planned that these vaccines will be tested in the USA in the next few months, and it is hoped that clinical trials in South Africa will start in 2008.

A phase I trial for an HIV vaccine generally involves volunteers who are at low risk for infection, who do not engage in risky sexual behaviours or intravenous drug use. 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 licenced for public use after it has been tested and found successful in all three phases.

South Africa has been involved in a number of clinical trials for HIV test vaccines since 2003 but this will be the first for products developed in South Africa by South African scientists.   

SAAVI is extremely gratified that these test HIV vaccines are edging closer to human clinical trials. However, 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.