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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.

Original publication

DOI

10.1016/j.vaccine.2014.04.022

Type

Journal article

Journal

Vaccine

Publication Date

20/08/2014

Volume

32

Pages

4708 - 4712

Keywords

Ethics, International research, Placebo controls, Risk, Trial design, Vaccine trials, Guidelines as Topic, Placebos, Randomized Controlled Trials as Topic, Research Design, Vaccines, World Health Organization