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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Simulation-guided phase 3 trial design to evaluate vaccine effectiveness to prevent Ebola virus disease infection: Statistical considerations, design rationale, and challenges
Clinical Trials, Volume 13, No. 1, Year 2016
Notification
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Description
Starting in December 2013, West Africa was overwhelmed with the deadliest outbreak of Ebola virus known to date, resulting in more than 27,500 cases and 11,000 deaths. In response to the epidemic, development of a heterologous prime-boost vaccine regimen was accelerated and involved preparation of a phase 3 effectiveness study. While individually randomized controlled trials are widely acknowledged as the gold standard for demonstrating the efficacy of a candidate vaccine, there was considerable debate on the ethical appropriateness of these designs in the context of an epidemic. A suitable phase 3 trial must convincingly ensure unbiased evaluation with sufficient statistical power. In addition, efficient evaluation of a vaccine candidate is required so that an effective vaccine can be immediately disseminated. This manuscript aims to present the statistical and modeling considerations, design rationale and challenges encountered due to the emergent, epidemic setting that led to the selection of a cluster-randomized phase 3 study design under field conditions. © 2016 The Author(s).
Authors & Co-Authors
Vandebosch, An
Belgium, Beerse
Janssen Research & Development
Mogg, Robin
Belgium, Beerse
Janssen Research & Development
Truyers, Carla
Belgium, Beerse
Janssen Research & Development
Greenwood, Brian M.
United Kingdom, London
London School of Hygiene & Tropical Medicine
Parys, Wim
Belgium, Beerse
Janssen Research & Development
Vangeneugden, Tony J.
Belgium, Beerse
Janssen Research & Development
Statistics
Citations: 4
Authors: 6
Affiliations: 2
Identifiers
Doi:
10.1177/1740774515621059
ISSN:
17407745
Research Areas
Infectious Diseases
Study Design
Randomised Control Trial
Study Locations
Multi-countries