TY - JOUR
T1 - Placebo use in vaccine trials
T2 - Recommendations of a WHO expert panel
AU - Rid, Annette
AU - Saxena, Abha
AU - Baqui, Abdullah H.
AU - Bhan, Anant
AU - Bines, Julie
AU - Bouesseau, Marie-Charlotte
AU - Caplan, Arthur
AU - Colgrove, James
AU - Dhai, Ames
AU - Gomez-Diaz, Rita
AU - Green, Shane K.
AU - Kang, Gagandeep
AU - Lagos, Rosanna
AU - Loh, Patricia
AU - London, Alex John
AU - Mulholland, Kim
AU - Neels, Pieter
AU - Pitisuttithum, Punee
AU - Sarr, Samba Cor
AU - Selgelid, Michael
AU - Sheehan, Mark
AU - Smith, Peter G.
PY - 2014/8/20
Y1 - 2014/8/20
N2 - 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.
AB - 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.
U2 - 10.1016/j.vaccine.2014.04.022
DO - 10.1016/j.vaccine.2014.04.022
M3 - Article
SN - 0264-410X
VL - 32
SP - 4708
EP - 4712
JO - Vaccine
JF - Vaccine
IS - 37
ER -