Central Data Catalog


Type Journal Article - Clinical Infectious Diseases
Title Ethical challenges and lessons learned during the clinical development of a group A meningococcal conjugate vaccine
Volume 61
Issue suppl_5
Publication (Day/Month/Year) 2015
Page numbers S422-S427
URL https://doi.org/10.1093/cid/civ598
Background. The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards.

Methods. Because of the public–private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access.

Results. Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts.

Conclusions. Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved.
Lionel Martellet, Samba O Sow , Aldiouma Diallo , Abraham Hodgson , Beate Kampmann , Siddhivinayak Hirve , Milagritos Tapia , Fadima Cheick Haidara , Assane Ndiaye , Bou Diarra , Patrick Odum Ansah , Adebayo Akinsola , Olubukola T Idoko , Richard A Adegbola , Ashish Bavdekar , Sanjay Juvekar , Simonetta Viviani , Godwin C Enwere , Elisa Marchetti , Julie Chaumont , Marie-Francoise Makadi , Flore Pallardy , Prasad S Kulkarni , Marie-Pierre Preziosi , and F Marc LaForce. "Ethical challenges and lessons learned during the clinical development of a group A meningococcal conjugate vaccine." Clinical Infectious Diseases 61, no. suppl_5 (2015): S422-S427.
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