[Free and informed consent in context of vaccine trials in rural Africa]. / Le consentement individuel, libre et éclairé dans le cadre des essais de vaccin en milieu rural Africain.

In biomedical research, the necessity to obtain free and informed consent of any participants taking part in a medical trial, recognized in the 1980s, has now become a universal principle. However, depending on the context, this principle comes up against many obstacles which can even question the objectivity intended by obtaining consent. In fact, in African societies, perception schemes and social organization reproduce the social hierarchies corresponding to the different decision-making spheres. In these societies, the opinion of elders, family and the whole community takes precedent over the individual. Consent brings up the issue of conciliation between general opinion and that of the individual, cultural and universal values, and the individual and the community. Free and informed consent is still a process in progress which needs to take into account the socio-cultural factors of the community. It is an essential issue which needs to resolved within the African context.

Ethics committees in western and central Africa: concrete foundations.

The involvement of developing countries in international clinical trials is necessary for the development of appropriate medicines for local populations. However, the absence of appropriate structures for ethical review represents a barrier for certain countries. Currently there is very little information available on existing structures dedicated to ethics in western and central Africa. This article briefly describes historical milestones in the development of networks dedicated to capacity building in ethical review in these regions and outlines the major conclusions of two workshops on this issue, which were held in September and October 2002 in Libreville, Gabon, and Paris, France. The workshops were the culmination of collaboration between the African Malaria Network Trust (AMANET) and the Pan African Bioethics Initiative (PABIN). They produced an update on ethics organizations with regard to mission, function, activities, members, and contact people, in eight countries within the regions discussed. As a result of the commitment of mandated delegates, a further prominent outcome followed these workshops: the creation of national structures, where none existed before, dedicated to the ethical review of clinical trials.

Safety and immunogenicity of the Plasmodium falciparum merozoite surface protein-3 long synthetic peptide (MSP3-LSP) malaria vaccine in healthy, semi-immune adult males in Burkina Faso, West Africa.

UNLABELLED: The merozoite surface protein-3 long synthetic peptide (MSP3-LSP) comprises the amino acid sequence 186-276 of the Plasmodium falciparum protein MSP3. It is currently in development as an erythrocytic stage (blood stage) malaria vaccine candidate. We report here the first data on the safety, reactogenicity and immunogenicity of three doses of MSP3-LSP, adjuvanted with aluminium hydroxide, in healthy male adults living in a malaria endemic area. METHODS: A phase 1b single-blind controlled trial was performed in the village of Balonghin in Burkina Faso. Thirty male volunteers aged 18-40 years were randomised to receive either three doses of 30 microg MSP3-LSP or 0.5 ml of tetanus toxoid vaccine. The second and third vaccine doses were given 28 and 112 days after the first dose. We followed participants for 1 year. RESULTS: There were no serious adverse events in either vaccine group. In both groups participants reported local reactions at the site of injection when compared to an earlier trial in European volunteers. Only one systemic adverse event (tachycardia) was identified which occurred immediately after the first vaccination in one individual receiving MSP3-LSP. No clinically significant biological abnormalities following vaccination were observed. Humoral immune responses (IgG, IgG subclasses, IgM) to MSP3-LSP peptide were similar in the two groups following vaccination. Some cell-mediated immune responses appeared to differ between the two vaccine groups. After the second dose of MSP3-LSP, there appeared to be a marked increase in the lymphocyte proliferation index and IFN-gamma in response to stimulation with MSP3-LSP. CONCLUSION: These data suggest that three doses of 30 microg MSP3-LSP when administered subcutaneously on days 0, 28 and 112 are well-tolerated by adult males previously exposed to natural P. falciparum infection. They also suggest that MSP3-LSP is able to stimulate an enhanced cell-mediated immune response in individuals with some degree of preexisting immunity.