Conducting Vaccine Clinical Trials in Sub-Saharan Africa: Operational Challenges and Lessons Learned From the Meningitis Vaccine Project

The Meningitis Vaccine Project (MVP) was established with the goal of developing, testing, licensing, and introducing an affordable group A meningococcal conjugate vaccine for Africa. The authors of this article, published in Vaccine, describe the main operational issues encountered in three studies to evaluate the safety and immunogenicity of MenAfriVac™, a monovalent group A conjugate vaccine. The studies were conducted in parallel among 2,700 subjects aged between 2 months and 29 years enrolled across four trial sites located in Mali, The Gambia, Senegal, and Ghana between 2006 and 2009. Many important lessons were learned during the preparation, setup, and implementation of the MVP clinical program. The authors provide this summary in the effort to help other vaccine development programs identify efficient pathways for successful implementation of clinical trials in low-resource settings. ABSTRACT ONLY. (Learn how users in developing countries can gain free access to journal articles.)

Author(s): Marchetti E, Mazarin-Diop V, Chaumont J, et al.

Published: 2012

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    Citation: Marchetti E, Mazarin-Diop V, Chaumont J, et al. Conducting Vaccine Clinical Trials in Sub-Saharan Africa: Operational Challenges and Lessons Learned From the Meningitis Vaccine Project. Vaccine. 2012; Early Online Publication.