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EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country

BACKGROUND/AIMS: During the 2014–2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was establish...

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Autores principales: Mooney, Thomas, Smout, Elizabeth, Leigh, Bailah, Greenwood, Brian, Enria, Luisa, Ishola, David, Manno, Daniela, Samai, Mohamed, Douoguih, Macaya, Watson-Jones, Deborah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: SAGE Publications 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136072/
https://www.ncbi.nlm.nih.gov/pubmed/29895178
http://dx.doi.org/10.1177/1740774518780678
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author Mooney, Thomas
Smout, Elizabeth
Leigh, Bailah
Greenwood, Brian
Enria, Luisa
Ishola, David
Manno, Daniela
Samai, Mohamed
Douoguih, Macaya
Watson-Jones, Deborah
author_facet Mooney, Thomas
Smout, Elizabeth
Leigh, Bailah
Greenwood, Brian
Enria, Luisa
Ishola, David
Manno, Daniela
Samai, Mohamed
Douoguih, Macaya
Watson-Jones, Deborah
author_sort Mooney, Thomas
collection PubMed
description BACKGROUND/AIMS: During the 2014–2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. METHODS: This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations. RESULTS: Establishing a clinical trial during an outbreak brought some unique challenges, including those related to trial design and the regulatory environment, operational issues, and community engagement. The situation was further complicated by the weak infrastructure and limited experience of clinical trials in Sierra Leone. However, operating in an outbreak context also brought some benefits to the research team, including strong stakeholder support. The EBOVAC-Salone study recruited participants both during and after the outbreak, leading to additional challenges to trial implementation during the post-outbreak transition. CONCLUSION: Many lessons have been learned about setting up and implementing a clinical trial during a devastating Ebola epidemic, and some of the experiences of the EBOVAC-Salone team were mirrored by those of other researchers operating in the region. Common to several of these research groups is a recommendation that research should be more closely incorporated into outbreak response planning, which could expedite the establishment of timely and appropriate research projects. We recommend that the lessons learned by researchers during the West African Ebola epidemic are built into programmes and strategies to improve the responses to future epidemics, wherever they occur.
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spelling pubmed-61360722018-09-25 EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country Mooney, Thomas Smout, Elizabeth Leigh, Bailah Greenwood, Brian Enria, Luisa Ishola, David Manno, Daniela Samai, Mohamed Douoguih, Macaya Watson-Jones, Deborah Clin Trials Design BACKGROUND/AIMS: During the 2014–2016 West African Ebola epidemic, clinical trials were fast-tracked in order to identify prophylactic vaccines and experimental treatments that might be useful in preventing or treating Ebola. These trials included the ongoing EBOVAC-Salone study, which was established and implemented in Sierra Leone to assess the safety and immunogenicity of the Ad26.ZEBOV/MVA-BN-Filo prime-boost Ebola vaccine regimen. METHODS: This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations. RESULTS: Establishing a clinical trial during an outbreak brought some unique challenges, including those related to trial design and the regulatory environment, operational issues, and community engagement. The situation was further complicated by the weak infrastructure and limited experience of clinical trials in Sierra Leone. However, operating in an outbreak context also brought some benefits to the research team, including strong stakeholder support. The EBOVAC-Salone study recruited participants both during and after the outbreak, leading to additional challenges to trial implementation during the post-outbreak transition. CONCLUSION: Many lessons have been learned about setting up and implementing a clinical trial during a devastating Ebola epidemic, and some of the experiences of the EBOVAC-Salone team were mirrored by those of other researchers operating in the region. Common to several of these research groups is a recommendation that research should be more closely incorporated into outbreak response planning, which could expedite the establishment of timely and appropriate research projects. We recommend that the lessons learned by researchers during the West African Ebola epidemic are built into programmes and strategies to improve the responses to future epidemics, wherever they occur. SAGE Publications 2018-06-12 2018-10 /pmc/articles/PMC6136072/ /pubmed/29895178 http://dx.doi.org/10.1177/1740774518780678 Text en © The Author(s) 2018 http://creativecommons.org/licenses/by/4.0/ This article is distributed under the terms of the Creative Commons Attribution 4.0 License (http://www.creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).
spellingShingle Design
Mooney, Thomas
Smout, Elizabeth
Leigh, Bailah
Greenwood, Brian
Enria, Luisa
Ishola, David
Manno, Daniela
Samai, Mohamed
Douoguih, Macaya
Watson-Jones, Deborah
EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
title EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
title_full EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
title_fullStr EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
title_full_unstemmed EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
title_short EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
title_sort ebovac-salone: lessons learned from implementing an ebola vaccine trial in an ebola-affected country
topic Design
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6136072/
https://www.ncbi.nlm.nih.gov/pubmed/29895178
http://dx.doi.org/10.1177/1740774518780678
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