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Title: Placebo use in vaccine trials: Recommendations of a WHO expert panel
Authors: Annette Rid
Abha Saxena
Abdhullah H. Baqui
Anant Bhan
Julie Bines
Marie Charlotte Bouesseau
Arthur Caplan
James Colgrove
Ames Dhai
Rita Gomez-Diaz
Shane K. Green
Gagandeep Kang
Rosanna Lagos
Patricia Loh
Alex John London
Kim Mulholland
Pieter Neels
Punee Pitisuttithum
Samba Cor Sarr
Michael Selgelid
Mark Sheehan
Peter G. Smith
King's College London
Organisation Mondiale de la Sante
Johns Hopkins Bloomberg School of Public Health
University of Toronto
University of Melbourne
NYU School of Medicine
Columbia University Medical Center
University of the Witwatersrand, Faculty of Health Sciences
Instituto Mexicano del Seguro Social
Saint Michael's Hospital University of Toronto
Christian Medical College, Vellore
Hospital de Ninos Robeto del Rio
Melbourne Law School
Carnegie Mellon University
London School of Hygiene & Tropical Medicine
Vaccine Advice BVBA
Mahidol University
Ministry of Health and Social Action 1
Monash University
University of Oxford
Keywords: Biochemistry, Genetics and Molecular Biology;Immunology and Microbiology;Medicine;Veterinary
Issue Date: 20-Aug-2014
Citation: Vaccine. Vol.32, No.37 (2014), 4708-4712
Abstract: Vaccines are among the most cost-effective interventions against infectious diseases. Many candidate vaccines targeting neglected diseases in low- and middle-income countries are now progressing to large-scale clinical testing. However, controversy surrounds the appropriate design of vaccine trials and, in particular, the use of unvaccinated controls (with or without placebo) when an efficacious vaccine already exists. This paper specifies four situations in which placebo use may be acceptable, provided that the study question cannot be answered in an active-controlled trial design; the risks of delaying or foregoing an efficacious vaccine are mitigated; the risks of using a placebo control are justified by the social and public health value of the research; and the research is responsive to local health needs. The four situations are: (1) developing a locally affordable vaccine, (2) evaluating the local safety and efficacy of an existing vaccine, (3) testing a new vaccine when an existing vaccine is considered inappropriate for local use (e.g. based on epidemiologic or demographic factors), and (4) determining the local burden of disease. © 2014 The Authors.
ISSN: 18732518
Appears in Collections:Scopus 2011-2015

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