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

Camacho, Anton; Carroll, Miles W; Dean, Natalie E; Doumbia, Moussa; Edmunds, W John; Egger, Matthias; Enwere, Godwin; Hall, Yper; Henao-Restrepo, Ana Maria; Hossmann, Stefanie; Keita, Sakoba; Kader Kondé, Mandy; Longini, Ira M; Mandal, Sema; Norheim, Gunnstein; Riveros, Ximena; Rottingen, John-Arne; Trelle, Sven; Vicari, Andrea S; Watle, Sara V; ... (2015). The ring vaccination trial: a novel cluster randomised controlled trial design to evaluate vaccine efficacy and effectiveness during outbreaks, with special reference to Ebola. BMJ, 351, h3740. BMJ Publishing Group 10.1136/bmj.h3740

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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.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Pre-clinic Human Medicine > CTU Bern
04 Faculty of Medicine > Pre-clinic Human Medicine > Institute of Social and Preventive Medicine

UniBE Contributor:

Egger, Matthias; Hossmann, Stefanie and Trelle, Sven

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

1756-1833

Publisher:

BMJ Publishing Group

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

29 Jul 2015 13:42

Last Modified:

08 Sep 2017 15:23

Publisher DOI:

10.1136/bmj.h3740

PubMed ID:

26215666

BORIS DOI:

10.7892/boris.70625

URI:

https://boris.unibe.ch/id/eprint/70625

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