Publication:
Placebo use in vaccine trials: Recommendations of a WHO expert panel

Issued Date

2014-08-20

Resource Type

Note

ISSN

18732518
0264410X

DOI

10.1016/j.vaccine.2014.04.022

Other identifier(s)

2-s2.0-84905221885

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

Vaccine. Vol.32, No.37 (2014), 4708-4712

Suggested Citation

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 Placebo use in vaccine trials: Recommendations of a WHO expert panel. Vaccine. Vol.32, No.37 (2014), 4708-4712. doi:10.1016/j.vaccine.2014.04.022 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/33231

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Title

Placebo use in vaccine trials: Recommendations of a WHO expert panel

Author(s)

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

Other Contributor(s)

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

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.

Keyword(s)

Biochemistry, Genetics and Molecular Biology
 Immunology and Microbiology
 Medicine
 Veterinary

Availability

URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/33231

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