title: Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.
abstract: 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.
  
  
  BACKGROUND
  ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007).
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Lionel
authors.initials: L
authors.lastname: Martellet
authors.affiliation: Centre pour le Développement des Vaccins, Bamako, Mali.
authors.forename: Samba O
authors.initials: SO
authors.lastname: Sow
authors.affiliation: Institut pour la Recherche et le Développement, Niakhar, Senegal.
authors.forename: Aldiouma
authors.initials: A
authors.lastname: Diallo
authors.affiliation: Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana.
authors.forename: Abraham
authors.initials: A
authors.lastname: Hodgson
authors.affiliation: Vaccines and Immunity Theme, Medical Research Council Unit, Basse, The Gambia.
authors.forename: Beate
authors.initials: B
authors.lastname: Kampmann
authors.affiliation: Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital Research Centre, Rasta Peth, Pune, India.
authors.forename: Siddhivinayak
authors.initials: S
authors.lastname: Hirve
authors.affiliation: Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.
authors.forename: Milagritos
authors.initials: M
authors.lastname: Tapia
authors.affiliation: Centre pour le Développement des Vaccins, Bamako, Mali.
authors.forename: Fadima Cheick
authors.initials: FC
authors.lastname: Haidara
authors.affiliation: Institut pour la Recherche et le Développement, Niakhar, Senegal.
authors.forename: Assane
authors.initials: A
authors.lastname: Ndiaye
authors.affiliation: Institut pour la Recherche et le Développement, Niakhar, Senegal.
authors.forename: Bou
authors.initials: B
authors.lastname: Diarra
authors.affiliation: Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana.
authors.forename: Patrick Odum
authors.initials: PO
authors.lastname: Ansah
authors.affiliation: Vaccines and Immunity Theme, Medical Research Council Unit, Basse, The Gambia.
authors.forename: Adebayo
authors.initials: A
authors.lastname: Akinsola
authors.affiliation: Vaccines and Immunity Theme, Medical Research Council Unit, Basse, The Gambia.
authors.forename: Olubukola T
authors.initials: OT
authors.lastname: Idoko
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Adegbola
authors.affiliation: Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital Research Centre, Rasta Peth, Pune, India.
authors.forename: Ashish
authors.initials: A
authors.lastname: Bavdekar
authors.affiliation: Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital Research Centre, Rasta Peth, Pune, India.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Juvekar
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Simonetta
authors.initials: S
authors.lastname: Viviani
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Godwin C
authors.initials: GC
authors.lastname: Enwere
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Elisa
authors.initials: E
authors.lastname: Marchetti
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Chaumont
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Marie-Francoise
authors.initials: MF
authors.lastname: Makadi
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
authors.forename: Flore
authors.initials: F
authors.lastname: Pallardy
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: Prasad S
authors.initials: PS
authors.lastname: Kulkarni
authors.affiliation: Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.
authors.forename: Marie-Pierre
authors.initials: MP
authors.lastname: Preziosi
authors.affiliation: Serum Institute of India, Ltd, Pune.
authors.forename: F Marc
authors.initials: FM
authors.lastname: LaForce
mesh_terms: D000354:Africa, Western; D002986:Clinical Trials as Topic / Q000941:ethics*; D006801:Humans; D007194:India; D007391:International Cooperation; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000276:immunology*; D055818:Public-Private Sector Partnerships; D014611:Vaccination / Q000941:ethics*
chemical_list: C573970:MenAfriVac; D022401:Meningococcal Vaccines
keywords: developing countries; ethics; ethics committees; informed consent; subject protection