2020 Jun 25;18(1):190. doi: 10.1186/s12916-020-01624-8.AIMS Public Health. The allocation sequence was generated by an independent statistician using randomly varying block lengths and is held on the electronic data management system with no access for staff involved in study recruitment.Once the ring is defined and randomised, informed consent is obtained from willing and eligible members of the ring. 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 (Ring vaccination trials are adaptive, can be run until disease elimination, allow interim analysis, and can go dormant during inter-epidemic periods.Evaluating the efficacy of novel vaccines and therapeutics in epidemics is challenging, with situations evolving rapidly and ethical concerns about research during public health emergenciesRing vaccination around cases was used successfully in the smallpox eradication programmeA novel cluster randomised control trial of immediate versus 21 day delayed ring vaccination against Ebola is underway in GuineaA ring vaccination trial tracks the epidemic, recruiting individuals at raised risk of infection due to their connection to a case: this design may both contribute to transmission interruption and have a higher power to detect vaccine efficacy than other study designsEvaluating vaccine efficacy during outbreaks can be challenging due to the timescales involved, ethical concerns around research methods, and field operational challenges such as cold chain management and effective communication with those affected. 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.
Free PMC article WJE conceived and designed the trial, analysed epidemiology data on Ebola in Guinea to inform sample size calculations, and helped draft the manuscript. Contacts are followed up in accordance with usual surveillance practices. MD contributed to the protocol and provided inputs on operational issues regarding trial design and implementing the trial, and helped draft the manuscript. GE contributed to the design of the trial, contributed to the protocol development, designed trial safety procedures, implemented the trial, and helped draft the manuscript. Variations on this trial design may thus in future be used to evaluate vaccines against rare diseases, such as meningococcal disease, or to evaluate vaccines that become available towards the end of an outbreak. This may be due to the concurrent non-vaccine control measures, or to issues with the timing of vaccine delivery and immunity onset relative to exposure.In conclusion, we propose a novel design to estimate efficacy and effectiveness of experimental vaccines during outbreaks, and have implemented this design to test a vaccine against EVD in Guinea.
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IML conceived and designed the trial, designed the statistical analysis plan, helped prepare the first draft the manuscript and revised the manuscript. GN conceived and designed the trial, prepared the first draft of the protocol, contributed to ethical and regulatory approval and community engagement planning, and helped draft the manuscript. 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. SVW contributed to the protocol and helped draft the manuscript. Epub 2015 Aug 3.Henao-Restrepo AM, Camacho A, Longini IM, Watson CH, Edmunds WJ, Egger M, Carroll MW, Dean NE, Diatta I, Doumbia M, Draguez B, Duraffour S, Enwere G, Grais R, Gunther S, Gsell PS, Hossmann S, Watle SV, Kondé MK, Kéïta S, Kone S, Kuisma E, Levine MM, Mandal S, Mauget T, Norheim G, Riveros X, Soumah A, Trelle S, Vicari AS, Røttingen JA, Kieny MP.Lancet.
This was deemed unacceptable in Guinea because of national and international concerns about leaving vulnerable individuals unprotected against EVD when a potentially effective vaccine was available.The recruitment of ring vaccination trial study participants is driven by the detection of new cases. To estimate the design effect for the trial, it is necessary to assume a particular intraclass correlation coefficient. The study is open label, so blinding of participants and field teams is not possible. 2019 Nov 20;6(4):502-513. doi: 10.3934/publichealth.2019.4.502.
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