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Clin Infect Dis. 2015 Nov 15;61 Suppl 5:S422-7. doi: 10.1093/cid/civ598.

Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.

Author information

1
Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
2
Centre pour le Développement des Vaccins, Bamako, Mali.
3
Institut pour la Recherche et le Développement, Niakhar, Senegal.
4
Navrongo Health Research Centre, Ghana Health Service, Navrongo, Ghana.
5
Vaccines and Immunity Theme, Medical Research Council Unit, Basse, The Gambia.
6
Shirdi Sai Baba Hospital, Vadu/King Edward Memorial Hospital Research Centre, Rasta Peth, Pune, India.
7
Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore.
8
GlaxoSmithKline Vaccines, Wavre, Belgium.
9
Serum Institute of India, Ltd, Pune.
10
Meningitis Vaccine Project, PATH, Ferney-Voltaire, France Meningitis Vaccine Project, Department of Immunization, Vaccines and Biologicals, World Health Organization, Geneva, Switzerland.

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.

CLINICAL TRIALS REGISTRATION:

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).

KEYWORDS:

developing countries; ethics; ethics committees; informed consent; subject protection

PMID:
26553670
PMCID:
PMC4639500
DOI:
10.1093/cid/civ598
[Indexed for MEDLINE]
Free PMC Article

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