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Mooney, Thomas, Smout, Elizabeth, Leigh, Bailah, Greenwood, Brian, Enria, Luisa, Ishola, David, Manno, Daniela, Samai, Mohamed, Douoguih, Macaya and Watson-Jones, Deborah (2018) 'EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country'. Clinical Trials, Vol 15, Issue 5, pp. 436-443.
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Abstract
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 EBOVACSalone
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.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | NOT_LSTM |
| Subjects: | QW Microbiology and Immunology > Immunotherapy and Hypersensitivity > QW 806 Vaccination WC Communicable Diseases > Virus Diseases > General Virus Diseases > WC 500 Virus diseases (General or not elsewhere classified) |
| Faculty: Department: | Clinical Sciences & International Health > International Public Health Department |
| Digital Object Identifer (DOI): | https://doi.org/10.1177/1740774518780678 |
| Depositing User: | Rachel Dominguez |
| Date Deposited: | 15 Jun 2023 08:28 |
| Last Modified: | 15 Jun 2023 08:28 |
| URI: | https://archive.lstmed.ac.uk/id/eprint/22629 |
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