Journal article
Placebo use in vaccine trials: Recommendations of a WHO expert panel
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.
Authors
- Abdhullah H. Baqui
- Abha Saxena
- Alex John London
- Ames Dhai
- Anant Bhan
- Annette Rid
- Arthur Caplan
- Gagandeep Kang
- James Colgrove
- Julie Bines
- Kim Mulholland
- Marie-Charlotte Bouesseau
- Mark Sheehan
- Michael Selgelid
- Patricia Loh
- Peter G. Smith
- Pieter Neels
- Punee Pitisuttithum
- Rita Gomez-Diaz
- Rosanna Lagos
- Samba Cor Sarr
- Shane K. Green
Languages
- English
Publication year
2014
Journal
Vaccine
Volume
37
Type
Journal article
Categories
- Vaccines & delivery devices
Organisations
- World Health Organisation (WHO)