HIV Vaccine Trials Network

All HIV vaccine trials in South Africa have been put on hold following the failure of the Phambili HIV vaccine trial.

The South African AIDS Vaccine Initiative (Saavi), which is supported by power parastatal Eskom and the South African government, announced on Thursday the start of the first large-scale test of a concept HIV vaccine -- which will involve 3 000 participants in South Africa.

PART-TIME EMPLOYMENT: SOCIAL SCIENCE RESEARCH Contact: Nicola Barsdorf Email: barsdorfn@ukzn.ac.za Tel: 072 184 7536

The South African AIDS Vaccine Initiative (SAAVI) on Monday announced the start of the first of several human trials to be conducted in the country. According to Dr Glenda Gray, national principal investigator of the tests, Phase 1 of the trials includes concurrent testing of a preventive HIV/AIDS candidate, AVX101, in the United States and South Africa. The HIV Vaccine Trials Network, the vaccine research arm of the US National Institutes of Health (NIH), will undertake the US tests. The vaccine trials, conducted in Soweto and the port city of Durban, will be looking at the safety of the vaccine, and how the immune system responds, Gray said during a press briefing. A total of 24 participants in South Africa are involved in the first phase. A trial of another vaccine, HIVA.MVA, designed by the University of Nairobi in Kenya and Oxford University in the United Kingdom, will start in South Africa next week with up to 55 volunteers. The first phase of human trials of the vaccine has been completed in Kenya and is underway in Uganda. A key difference in all these trials will be the involvement of communities, Dr Andrew Robinson of the SAAVI HIV Vaccine Research Unit in Durban, noted. In other vaccine trials [communities are] usually involved at the end, and it is an unequal partnership between scientists and communities. It was therefore essential to develop appropriate community expectations around the announcement of the start of the trials, SAAVI director Dr Tim Tucker warned. What we are trying to put across is that a vaccine is not a panacea. We still need to advocate for health sexual practices. Nevertheless, the vaccine body's community preparedness efforts were starting to bear fruit, said SAAVI deputy director Dr Ashraaf Grimwood. The group has managed to reach 700 South African organisations, and has held up to 90 workshops since 2000. SAAVI now runs a toll-free vaccine line to answer the public's questions and has also developed school modules on HIV/AIDS vaccines.(Source: Plusnews, IRIN, 3 November 2003) LINK//\// For more on SAAVI: http://www.saavi.org

South Africa is expected to begin it's first Aids vaccine trials at the end of September, following the approval by the Medicines Control Council (MCC) of a second HIV preventative vaccine candidate. The trials will form phase one of three trials that could take seven to 10 years to complete. The most recently approved vaccine candidate, named HIVA.MVA, was designed by the University of Nairobi in Kenya and the University of Oxford in the United Kingdom. Phase one human trials of the vaccine candidate have already have been completed in Kenya and the UK and are underway in Uganda. The trials are sponsored by the nonprofit International Aids Vaccine Initiative (IAVI). In June, the MCC gave approval for a phase one trial of AVX101, designed by the US biotechnology firm AlphaVax Inc. The trial will be conducted by the HIV Vaccine Trials Network of the US government's National Institute of Allergy and Infectious Diseases. A Phase One trial of AVX101 was recently completed in the US. The trials of HIVA.MVA and the AlphaVax candidate are separate, but will be conducted at the same sites: the Perinatal HIV Research Unit (PHRU) of the University of the Witwatersrand at the Chris Hani Baragwanath Hospital in Soweto and the SAAVI HIV Vaccine Research Unit at the Medical Research Council in Durban. Professor James McIntyre, Principal Investigator for the Aids vaccine trial sites in South Africa, said: South Africa's research community has linked hands with researchers cross three continents-Europe, North America and Africa-in the global effort to find a vaccine against Aids. There is no risk of either HIVA.MVA or AVX101 causing HIV infection or Aids. Neither vaccine candidate contains HIV or any substance from HIV infected individuals. A preventive vaccine would be given to people who are HIV negative, to prevent HIV infection. IAVI's HIVA.MVA and AlphaVax's AVX101 employ different vaccine design strategies. HIVA.MVA uses a vaccine strategy called modified vaccinia Ankara, a variant of the basis for the smallpox vaccine. AVX101 uses a carrier for it's vaccine called the Venezuelan Equine Encephalitis alphavirus vector. By studying different vaccine design strategies at once, rather than one at a time, South Africa will help reduce the time needed to identify which is the most effective, said Dr Seth Berkley, President and CEO of IAVI. In the search for an Aids vaccine, speed is of the essence. A preventive vaccine is our best hope to end the spread of an epidemic that infects 15,000 men, women and children around the world every day, Dr Berkley said. The Phase one trials will initially enroll roughly 50 volunteers each. Their aim is to test safety and gather preliminary data on the ability of the vaccine candidates to stimulate the immune system. By conducting the HIVA.MVA and AVX101 trials side by side, South Africa will help gather data to address how an AIDS vaccine may be able to combat the varying subtypes of HIV that are circulating. IAVI's HIVA.MVA is based on subtype A, which is common in east Africa. AlphaVax's AVX101 is based on subtype C, the subtype most common in South Africa. Ideally, a single Aids vaccine will be highly effective against all subtypes of HIV, said Dr. Wayne Koff, IAVI's senior vice president for Research and Development. Preliminary indications are that both of the vaccine candidates currently approved for testing in South Africa hold promise for meeting this goal, but only human trials will tell us for sure. (Source: Sapa, Business Day, 26 August 2003)

South Africa's first human vaccine safety trials have entered a critical stage of development, which, if all goes according to plan, will see participants receiving the initial dose before June. Dr Tim Tucker, director of the South African AIDS Vaccine Initiative, has confirmed that the final stages of implementation are under way, with top-level discussions in progress. According to human rights lawyer Anne Strode of the University of Natal's department of law in Pietermaritzburg, one of the main areas of concern being discussed this week by the country's top scientists and the Department of Health was the question of treatment for participants if they become HIV-positive during the trial period. She outlined some of the ethics that needed to be fully understood by participants and researchers. There was also a need for external structures where participants could discuss problems and concerns arising from the trials, she added. Among the major aims of the ethics process was to ensure that participants knew the methods used for the research, how many blood tests or clinic visits might be required, potential risks, expected benefits, the right to withdraw, and confidentiality. One of the thorny ethical issues facing researchers was the gaining of informed consent from people in rural areas where cultural dynamics came into play. Often in these cases, individual consent does not exist, Strode added. A wife cannot consent to participate in a trial without the approval of her husband or community leaders. These are ethical considerations that still need work. (Source: Liz Clarke: The Star, 26 February 2003)

South Africa is to test a new TB vaccine that could reduce the number of people infected by the killer disease worldwide. More than 100 000 South Africans are infected with the disease every year, of them 25 000 children. News of the new vaccine trial emerged this week at an international vaccine conference in Cape Town, attended by South African and world vaccine experts. The new vaccine - the most promising in 80 years since the introduction of the first TB vaccine that is still in use - is due to start this year in the Worcester area of the Western Cape, co-coordinated by infectious diseases expert Professor Greg Hussey, head of paediatric infectious diseases at the University of Cape Town. The trial, expected to last between three to five years, is a joint venture between South Africa, the University of Los Angeles and an American development agency. It follows a worldwide resurgence of TB and TB research, due largely to the HIV/AIDS pandemic. People who are HIV-positive are more at risk of developing TB and this has led to a resurgence of TB vaccines. Researchers at this week's conference were also upbeat about the chances of a HIV vaccine, expected within the next 10 years. A number of separate HIV vaccine trials across the globe are nearing the human trial phase. South Africa spends about R100-million a year on vaccinations. (Source: Sunday Times, 14 April 2002)

South African scientists have completed their laboratory research on a potential HIV vaccine, and the country's first human trials involving up to 20 people are expected to begin in the third quarter of the year. This, is according to Zo Mbelle, project manager for the South African HIV Vaccine Action Campaign at the Medical Research Council (MRC). Describing the process as very, very, exciting, Mbelle said the human trial of the Venezuelan encephalitis virus vaccine would be conducted at RK Khan Hospital, a private hospital in Durban. Kenya launched Africa's first human trial of an HIV vaccine this week. However, the Kenyan candidate vaccine is based on HIV sub-type A, the most common form of the disease in East Africa, while HIV sub-type C is most prevalent in southern Africa. Michelle Galloway, MRC spokesperson on the South African vaccine initiative, confirmed that Alphavax, a US-based biotechnology company, which has been working on a similar vaccine for sub-type B in the US, will be making the substance which will be tested in the human trial here. Mbelle said: There are about 10 candidate vaccines being researched and developed in the country. Chris Hani Baragwanath Hospital has also applied to be a test site and is waiting for funding. It has not yet identified which candidate vaccine it wants to test. All HIV vaccine work in the country is co-ordinated by the South African Aids Vaccine Initiative. The Medicines Control Council is involved in the licensing and registration of the product.