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

Clinical Trials
Volume 15 Issue 5, October 2018
http://journals.sagepub.com/toc/ctja/15/5

Design
EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country
Thomas Mooney, Elizabeth Smout, Bailah Leigh, Brian Greenwood, Luisa Enria, David Ishola, Daniela Manno, Mohamed Samai, Macaya Douoguih, Deborah Watson-Jones
First Published June 12, 2018; pp. 436–443
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 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.