Idoko Olubukola T, Diallo Aldiouma, Sow Samba O, Hodgson Abraham, Akinsola Adebayo, Diarra Bou, Haidara Fadima Cheick, Ansah Patrick Odum, Kampmann Beate, Bouma Enricke, Preziosi Marie-Pierre, Enwere Godwin C
Vaccines and Immunity Theme, Medical Research Council Unit, Basse, The Gambia.
Institut de Recherche pour le Développement, Niakhar, Senegal.
Clin Infect Dis. 2015 Nov 15;61 Suppl 5(Suppl 5):S416-21. doi: 10.1093/cid/civ596.
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.
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.
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.
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.
ISRTCN78147026 (PsA-TT 002); ISRCTN87739946 (PsA-TT 003); ISRCTN82484612 (PsA-TT 004); PACTR ATMR2010030001913177 (PsA-TT 006); and PACTR201110000328305 (PsA-TT 007).
脑膜炎疫苗项目（MVP）旨在解决撒哈拉以南非洲地区流行性脑膜炎这一公共卫生问题，为此致力于研发一种A群脑膜炎球菌结合疫苗，即PsA-TT。
描述了4个临床试验地点的经验。采用了具有文化敏感性的协作策略来管理可接受的沟通方式、同意程序的特殊性、参与者的医疗问题、社区护理和死亡情况。
通过社区认可和积极的社区协作，临床试验得以成功完成。这些试验还增强了参与社区的能力，并积极致力于解决社区问题。
对社区社会文化现实的理解和整合是这些试验开展和被接受的主要资产。MVP在这些地点取得了成功，并为非洲未来的临床研究提供了一个良好范例。
ISRTCN78147026（PsA-TT 002）；ISRCTN87739946（PsA-TT 003）；ISRCTN82484612（PsA-TT 004）；PACTR ATMR2010030001913177（PsA-TT 006）；以及PACTR201110000328305（PsA-TT 007）。
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