Design of vaccine efficacy trials during public health emergencies
File(s)
Accepted version
Author(s)
Type
Journal Article
Abstract
Public Health Emergencies (PHEs) provide a complex and challenging environment for vaccine evaluation. Under the R&D Blueprint Plan of Action, the World Health Organization (WHO) has convened a group of experts to agree on standard procedures to rapidly evaluate experimental vaccines during PHEs while maintaining the highest scientific and ethical standards. The Blueprint priority diseases, selected for their likelihood to cause PHEs and the lack of adequate medical countermeasures,were used to frame our methodological discussions. Here, we outline major vaccine study designs to be used in PHEs and summarize high-level recommendations for their use in this setting. We recognize that the epidemiology and transmission dynamics of the Blueprint priority diseasesmay be highly uncertain and that the unique characteristics of the vaccines and outbreak settings may affect our study design. To address these challenges, our group underscores the need for novel, flexible,and responsive trial designs. We conclude that assignment to study groups using randomization is a key principle underlying rigorous study design and should be utilized except in exceptional circumstances. Advance planning for vaccine trial designs is critical for rapid and effective response to a PHE and to advance knowledge to address and mitigate future PHEs.
Date Issued
2019-07-03
Date Acceptance
2018-12-13
Citation
Science Translational Medicine, 2019, 11 (499)
ISSN
1946-6234
Publisher
American Association for the Advancement of Science
Journal / Book Title
Science Translational Medicine
Volume
11
Issue
499
Copyright Statement
© 2019 The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works http://www.sciencemag.org/about/science-licenses-journal-article-reuse. This is the author’s version of the work. It is posted here by permission of the AAAS for personal use, not for redistribution. The definitive version was published in Science Translational Medicine, DOI: https://stm.sciencemag.org/content/11/499/eaat0360
Sponsor
Medical Research Council (MRC)
National Institute for Health Research
Medical Research Council (MRC)
Grant Number
MR/K010174/1B
HPRU-2012-10080
MR/R015600/1
Subjects
11 Medical and Health Sciences
06 Biological Sciences
Publication Status
Published