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

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.

journal_name

Vaccine

journal_title

Vaccine

authors

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

doi

10.1016/j.vaccine.2014.04.022

subject

Has Abstract

pub_date

2014-08-20 00:00:00

pages

4708-12

issue

37

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(14)00537-4

journal_volume

32

pub_type

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