Abstract
Background. The Meningitis Vaccine Project (MVP) was established to address epidemic meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate vaccine, PsA-TT.Methods. Experiences in 4 clinical trial sites are described. Culturally sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death.Results. The clinical trials were completed successfully through community acceptance and active community collaboration. The trials also strengthened the capacities in the participating communities, and actively worked to resolve community problems.Conclusions. The understanding and integration of sociocultural realities of communities were major assets in the conduct and acceptance of these trials. MVP succeeded in these sites and provided a sound example for future clinical studies in Africa.Clinical Trials Registration. ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007).
Highlights
The Meningitis Vaccine Project (MVP) was established to address epidemic meningitis as a public health problem in sub-Saharan Africa and, to that end, worked to develop a group A meningococcal conjugate vaccine, PsA-TT
MVP succeeded in these sites and provided a sound example for future clinical studies in Africa
The project developed a group A meningococcal conjugate vaccine (PsA-TT, MenAfriVac), which was tested for safety and efficacy in countries and populations that would benefit from such a vaccine
Summary
Sensitive collaborative strategies were adopted to manage acceptable communication methods, peculiarities with the consent process, participant medical issues, community care, and death. Conducting clinical trials in resource-limited communities is challenging. This article focuses on the clinical experiences in the following African sites: (1) Medical Research Council (MRC) Unit, The Gambia; (2) Navrongo Health Research Centre, Ghana; (3) Centre pour le Développement des Vaccins (CVD), Mali; and (4) Institut de Recherche pour le Développement, Senegal.
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