Only Time will Tell

Tuesday, 01 September 2009 10:59

The AIDS vaccine carries much hope for our developing country, however, some activists are questioning the wisdom of using valuable time and resources in an area that has been fraught with disappointment. But what if this works? In July, South Africa launched clinical trials of the first AIDS vaccine created by a developing country. The new vaccine targets the specific HIV strain that has ravaged South Africans and produced an AIDS epidemic. “It has been a very, very hard journey,” said lead scientist Professor Anna-Lise Williamson of the University of Cape Town (UCT), at a ceremony on 20 July attended by American health officials who gave technical help and manufactured the vaccine at the US National Institutes of Health. Williamson said she sees no choice for South Africa but to press ahead with trials to test the safety of the vaccine in humans. The tests follow the successful enrolment and vaccination of 12 volunteers in Boston, US, 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, Prof. Anthony Mbewu, president of the Medical Research Council of South Africa, 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.” The government was keen to ensure that once developed, it would be available at an affordable price, Mbewu said. South Africa was the site of the greatest setback to AIDS vaccine research when the most promising vaccine ever, produced by Merck & Co. and tested here in 2007, found that people who received the vaccine were more likely to contract HIV than those who did not. Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID) and a leading AIDS researcher, said South African scientists received more money from his institute’s research fund than any others in the world, except in the US. But he warned that “there are extraordinary challenges ahead”, referring to the years of testing needed now that South Africa has reached the clinical trial stage. Fauci said scientists do not understand why the search for an AIDS vaccine is so difficult, except that they are trying to do better than nature: “We have to develop a vaccine that does better even than natural protection.” At an international AIDS conference in Cape Town, Vice President Kgalema Motlanthe emphasised that the clinical trials were being held “under strict ethical rules”. The field of AIDS vaccine research is so filled with disappointments that some activists are questioning the wisdom of continuing such expensive investments, saying the money may be better spent on prevention and education. Mbewu said that the crisis in South Africa, where “we have the biggest problem” in the world, more than justifies the expenditure. 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. (Source: SAAVI/HVTN news release) SAAVI director Elise Levendal said the start of the safety trial was made possible by the excellent collaboration between researchers, scientists and communities. “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,” Prof. Williamson said. (Sources: Department of Health; SA Info) The trial has been reviewed by the US Food and Drug Administration, which allowed the trial to move forward through the usual review process. It has also been approved by the Medicines Control Council of South Africa 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. (Source: SA Info)

Last Updated on Friday, 23 April 2010 07:30