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

Rid, A; Saxena, A; Baqui, AH; Bhan, A; Bines, J; Bouesseau, MC; Caplan, A; Colgrove, J; Dhai, A; Gomez-Diaz, R; Green, SK; Kang, G; Lagos, R; Loh, P; London, AJ; Mulholland, K; Neels, P; Pitisuttithum, P; Sarr, SC; Selgelid, M; Sheehan, M; Smith, PG; (2014) Placebo use in vaccine trials: Recommendations of a WHO expert panel. Vaccine, 32 (37). pp. 4708-12. ISSN 0264-410X DOI:

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: 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.<br/>

Item Type: Article
Faculty and Department: Faculty of Epidemiology and Population Health > Dept of Infectious Disease Epidemiology
Research Centre: TB Centre
Tropical Epidemiology Group
PubMed ID: 24768580
Web of Science ID: 340979800003


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