Vaccine trial

The African Malaria Network Trust (AMANET) and researchers at the Malaria Research Training Center (MRTC), University of Bamako in Mali have launched a large scale study to evaluate the candidate malaria vaccine merozoite surface protein-3 long synthetic peptide (MSP3-LSP).

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.

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)

Many concerned South Africans, including radio DJs, have volunteered to be injected with the country's first HIV/AIDS prototype vaccine, according to researcher Salim Abdool Karim. We haven't selected the 48 subjects yet who will be part of the phase one trial, as we don't know when exactly we will start, said Karim, who is deputy vice-chancellor of research at Natal University. But people have been phoning, writing and emailing, saying they would like to take part. We are keeping a list of potential volunteers. We will need several hundred volunteers for vaccine trials. The 48 people to be tested in Durban need to be HIV-negative, in good health and at low risk of HIV infection, said Karim. The phase one trial will test the safety of the vaccine for use in humans, as the sample size is too small to test whether it will be effective in preventing HIV. Phase two will involve about 150 people and its main aim will be to see whether the vaccine stimulates an immune response to HIV in humans. A phase three trial would involve more than 10 000 people to test whether the vaccine prevents HIV infection. (Source: Health-E, 3 July 2001)