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

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 SelgelidMark Sheehan, Peter G. Smith

Research output: Contribution to journalComment/debatepeer-review

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.

Original languageEnglish (US)
Pages (from-to)4708-4712
Number of pages5
JournalVaccine
Volume32
Issue number37
DOIs
StatePublished - Aug 20 2014

Keywords

  • Ethics
  • International research
  • Placebo controls
  • Risk
  • Trial design
  • Vaccine trials

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

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