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Placebo use in vaccine trials: Recommendations of a WHO expert panel
- Source :
- Vaccine. (37):4708-4712
- Publisher :
- The Authors. Published by Elsevier Ltd.
-
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.
- Subjects :
- Research design
Trial design
Risk
medicine.medical_specialty
Placebo controls
Alternative medicine
Psychological intervention
Guidelines as Topic
Placebo
World Health Organization
Placebos
Immunology and Microbiology(all)
Health care
Epidemiology
medicine
Intensive care medicine
International research
Randomized Controlled Trials as Topic
Ethics
Vaccines
General Veterinary
General Immunology and Microbiology
business.industry
Public health
Public Health, Environmental and Occupational Health
veterinary(all)
3. Good health
Vaccination
Infectious Diseases
Research Design
Immunology
Molecular Medicine
business
Vaccine trials
Subjects
Details
- Language :
- English
- ISSN :
- 0264410X
- Issue :
- 37
- Database :
- OpenAIRE
- Journal :
- Vaccine
- Accession number :
- edsair.doi.dedup.....2646f2ee2e357bc03e0380f26f9886b1
- Full Text :
- https://doi.org/10.1016/j.vaccine.2014.04.022