This paper presents an ethical framework for addressing questions concerning placebo-controlled trials, as developed by a recent WHO expert panel. The framework sets out the conditions under which placebo use is clearly acceptable and clearly unacceptable in vaccine trials. It then specifies four situations in which the use of placebo controls may be ethically justified even when an efficacious vaccine exists. In these situations, it is necessary that the study question cannot be answered in an active-controlled trial design; that the risks of delaying or foregoing the efficacious vaccine are adequately
mitigated; that the risks of using a placebo control are justified by the social or public health value of the research; and that the research is
responsive to local health needs. The ultimate judgement about the acceptability of using a placebo control when selleck compound an efficacious vaccine exists will depend on the specifics of the given trial. It is therefore critical that investigators and sponsors develop the design of vaccine trials in close collaboration with host country stakeholders, and that RECs and others thoroughly evaluate study protocols based on the available selleck kinase inhibitor evidence and all relevant reasons. It is our hope that these recommendations will help to ensure that participants in vaccine trials are protected from unjustifiable risks, while facilitating the conduct of valuable and urgently needed vaccine research. Annette Rid, Abha Saxena and Peter Smith drafted the initial manuscript based on the WHO meeting report. All authors reviewed and revised the manuscript, and approved the final manuscript as submitted. The WHO Expert Consultation was supported by PATH, a non-profit organization funded by the Bill & Melinda Gates Foundation. Annette Rid received funding from the People Programme (Marie Curie Actions) of the European Union’s Seventh Framework Programme
(FP7/2007-2013) under REA grant agreement no. 301816. Peter G. Smith receives support from the MRC and DiFD (MR/K012126/1). Mark Sheehan is grateful for the support of the Oxford NIHR Biomedical Research Centre. Several authors of this paper have been involved in placebo-controlled vaccine trials that were conducted in situations in which a vaccine already existed that was at least partially efficacious against the conditions under much study. Many thanks to John Boslego and David Wendler for comments on a previous version of this manuscript. “
“In contrast to many other vaccines, influenza vaccines are frequently updated to be effective against newly evolving human influenza viruses that are likely to circulate in the following influenza season. WHO convenes technical consultations (vaccine composition meetings (VCM)) twice a year to provide guidance to national public health authorities and vaccine manufacturers on the viruses to be included in trivalent or quadrivalent influenza vaccines for the following influenza seasons in the Northern and Southern Hemispheres.
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