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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Conducting vaccine clinical trials in sub-Saharan Africa: Operational challenges and lessons learned from the Meningitis Vaccine Project
Vaccine, Volume 30, No. 48, Year 2012
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Description
Group A Neisseria meningitidis epidemics have been an important and unresolved public health problem in sub-Saharan Africa for over a century. The Meningitis Vaccine Project (MVP) was established in 2001 with the goal of developing, testing, licensing, and introducing an affordable group A meningococcal conjugate vaccine for Africa. A monovalent group A conjugate vaccine, MenAfriVac™, was developed at the Serum Institute of India Ltd. and tested in clinical trials at multiple trial sites in sub-Saharan African countries.The setup and successful conduct of ICH-GCP standard vaccine trials across multiple trial sites located in low-resource settings are challenging. We describe the main operational issues encountered in three randomized, observer-blind, active controlled studies to evaluate the safety and immunogenicity of MenAfriVac™. The studies were conducted in parallel among 2700 subjects aged between 2 months and 29 years of age enrolled across four trial sites located in Mali, The Gambia, Senegal, and Ghana between September 2006 and August 2009.Many important lessons were learned during the preparation, setup, and implementation of the Meningitis Vaccine Project clinical program. They are summarized here to help vaccine development programs identify efficient pathways for successful implementation of clinical trials in low-resource settings. © 2012 Elsevier Ltd.
Authors & Co-Authors
Marchetti, Elisa
France, Ferney-voltaire
Path
Mazarin-Diop, Véronique
Senegal
Agence Africaine de Recherche en Santé Humaine
Chaumont, Julie
France, Ferney-voltaire
Path
Martellet, Lionel
France, Ferney-voltaire
Path
Makadi, Marie Françoise
France, Ferney-voltaire
Path
Viviani, Simonetta
France, Ferney-voltaire
Path
Kulkarni, Prasad Suryakant
India, Pune
Serum Institute of India Ltd.
Préziosi, Marie Pierre
Switzerland, Geneva
Organisation Mondiale de la Santé
Statistics
Citations: 22
Authors: 8
Affiliations: 4
Identifiers
Doi:
10.1016/j.vaccine.2012.09.008
ISSN:
0264410X
e-ISSN:
18732518
Research Areas
Disability
Study Locations
Gambia
Ghana
Mali
Senegal