The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola

DOI
Publisher DOI
PubMed ID
26215666
Abstract
A World Health Organization expert meeting on Ebola vaccines proposed urgent safety and efficacy studies in response to the outbreak in West Africa. One approach to communicable disease control is ring vaccination of individuals at high risk of infection due to their social or geographical connection to a known case. This paper describes the protocol for a novel cluster randomised controlled trial design which uses ring vaccination.In the Ebola ça suffit ring vaccination trial, rings are randomised 1:1 to (a) immediate vaccination of eligible adults with single dose vaccination or (b) vaccination delayed by 21 days. Vaccine efficacy against disease is assessed in participants over equivalent periods from the day of randomisation. Secondary objectives include vaccine effectiveness at the level of the ring, and incidence of serious adverse events.Ring vaccination trials are adaptive, can be run until disease elimination, allow interim analysis, and can go dormant during inter-epidemic periods.
Date Issued
2015-07-27
Publication Type
Article
Subject(s)
Language(s)
en
Author(s)
Camacho, Anton
Carroll, Miles W
Dean, Natalie E
Doumbia, Moussa
Edmunds, W John
Enwere, Godwin
Hall, Yper
Henao-Restrepo, Ana Maria
Keita, Sakoba
Kader Kondé, Mandy
Longini, Ira M
Mandal, Sema
Norheim, Gunnstein
Riveros, Ximena
Rottingen, John-Arne
Vicari, Andrea S
Watle, Sara V
Watson, Conall H
Additional Credits
Journal
BMJ
Publisher
BMJ Publishing Group
ISSN
1756-1833
Access(Rights)
open.access
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