Design of vaccine efficacy trials during public health emergencies

Natalie E Dean; Pierre-Stéphane Gsell; Ron Brookmeyer; Victor De Gruttola; Christl A Donnelly; M Elizabeth Halloran; Momodou Jasseh; Martha Nason; Ximena Riveros; Conall H Watson; Ana Maria Henao-Restrepo; Ira M Longini

doi:10.1126/scitranslmed.aat0360

Design of vaccine efficacy trials during public health emergencies

Sci Transl Med. 2019 Jul 3;11(499):eaat0360. doi: 10.1126/scitranslmed.aat0360.

Authors

Affiliations

¹ Department of Biostatistics, University of Florida, Gainesville, FL, USA. nataliedean@ufl.edu ilongini@ufl.edu.
² World Health Organization, Geneva, Switzerland.
³ Department of Biostatistics, University of California, Los Angeles, Los Angeles, CA, USA.
⁴ Department of Biostatistics, Harvard University, Boston, MA, USA.
⁵ Department of Statistics, University of Oxford, Oxford, UK.
⁶ MRC Centre for Global Infectious Disease Analysis, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College London, London, UK.
⁷ Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
⁸ Department of Biostatistics, University of Washington, Seattle, WA, USA.
⁹ Medical Research Council, The Gambia at London School of Hygiene and Tropical Medicine, Fajara, The Gambia.
¹⁰ Biostatistics Research Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
¹¹ Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.

Abstract

Public health emergencies, such as an Ebola disease outbreak, provide a complex and challenging environment for the evaluation of candidate vaccines. Here, we outline the need for flexible and responsive vaccine trial designs to be used in public health emergencies, and we summarize recommendations for their use in this setting.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Review

MeSH terms

Clinical Trials as Topic*
Emergencies*
Endpoint Determination
Humans
Public Health*
Statistics as Topic
Vaccines / immunology*

Substances

Vaccines

Abstract

Publication types

MeSH terms

Substances

Grants and funding