22 July 2009
Clinical testing of two locally developed HIV vaccines has begun in Cape Town and Johannesburg, as part of the Medical Research Council’s South African Aids Vaccine Initiative (SAAVI).
The safety trial, being conducted jointly with the HIV Vaccine Trials Network and the US National Institute of Allergy and Infectious Diseases (NIAID), will test the two vaccines that were developed by the University of Cape Town through joint funding from SAAVI and the NIAID.
The tests follow the successful enrolment and vaccination of 12 volunteers in Boston, USA, and the local researchers plan to recruit 36 participants from the Crossroads Clinic in Cape Town and the Chris Hani Baragwanath Hospital in Johannesburg.
In a statement this week, MRC president Anthony Mbewu said that the development of the vaccines was the culmination of eight years of research and development that involved scientists from across South Africa and the rest of the globe.
“The vaccine designs are based on HIV subtype C, the dominant strain circulating in southern Africa,” he said. “They are the first HIV test vaccines developed in Africa to make it into human clinical trials.”
Vaccine design, manufacture
The test vaccines, called SAAVI MVA-C and SAAVI DNA-C2, have shown promising results in animal testing.
The DNA vaccine was constructed in South Africa using a plasmid backbone provided by the Dale and Betty Bumpers Vaccine Research Center of NIAID and manufactured in the US by Althea Technologies, while the MVA vaccine was designed by the team at UCT and constructed and manufactured in the US by Therion Biologics.
The vaccines will be tested in a prime-boost approach, with the SAAVI DNA-C2 vaccine being given to prime the immune response and the SAAVI MVA-C vaccine to boost or enhance the immune response.
SAAVI director Elise Levendal said the start of the safety trial was made possible by the excellent collaboration between researchers, scientists and communities.
Professor Anna-lise Williamson, head of the vaccine development team and joint staff member of UCT’s Institute for Infectious Disease and Molecular Medicine and the National Health Laboratory Services, explained that the transition from laboratory to human testing would not have been possible without the support of a large team from the University of Cape Town, together with national and international collaborators.
“An effective vaccine against HIV/Aids remains a top global health priority, and it is our hope that the evaluation of these vaccines in clinical trial will provide some important answers that will bring us closer towards this goal,” she said.
The trial has been reviewed by the US Food and Drug Administration, who allowed the trial to move forward through the usual review process. It has also been approved by the South African Medicines Control Council and the Directorate of Biosafety in the Department of Agriculture, which approves products using genetically modified organisms.
Institutional review boards or research ethics committees at each participating institution have also reviewed and approved the trial.
Professor Linda-Gail Bekker, principal investigator for the Cape Town trial site and director of the Desmond Tutu HIV Foundation, said researchers had been eagerly awaiting the go-ahead to begin recruiting participants for the landmark study.
“Both the Cape Town and Johannesburg sites have been preparing communities, potential recruits and undergoing site preparation for some time,” she said, adding that the sites had been preparing for many months in order to recruit the most suitable people.
“If data from this clinical trial is promising, we intend to move into the next phase of trials, which will involve about 200 participants and will look at further safety and immunogenicity data.”
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