Anton Camacho, Miles W Carroll, Natalie E Dean, Moussa Doumbia, W John Edmunds, Matthias Egger, Godwin Enwere, Yper Hall, Ana Maria Henao-Restrepo, Stefanie Hossman, Sakoba Keita, Mandy Kader Kondé, Ira M Longini, Sema Mandal, Gunnstein Norheim, Ximena Riveros, John-Arne Røttingen, Sven Trelle, Andrea S Vicari, Sara V Watle, Conall H Watson
BMJ
July 27, 2015
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.