Publication
Title
Conducting an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo : challenges, mitigations, and lessons learned
Author
Abstract
Conducting a vaccine trial in a low- and middle-income country (LMIC) can present unique challenges and lessons learned. This Ebola vaccine trial, enrolling 699 healthcare providers and frontliners and jointly set up by the University of Antwerp (Sponsor) and the University of Kinshasa (Principal Investigator (PI)), was conducted in Boende, a remote city in the Democratic Republic of the Congo (DRC), between December 2019 and October 2022 (ClinicalTrials.gov: NCT04186000). While being bound by strict ICH-GCP and international funder regulations, this trial, exemplary for being a public–private partnership, required collaboration between several international stakeholders (e.g., two universities, a pharmaceutical company, and a clinical research organization), local communities and government agencies. Here we address several logistical and administrative challenges, cultural differences, language barriers and regulatory, political, and ethical considerations over the trial’s 2.5-year duration, while tailoring and adapting the study to the specific local context. Lessons learned include the importance of clear communication with participants in all phases of the study, but also within the study team and among different stakeholders. Challenges, mitigations, and lessons learned are presented in nine categories (e.g., safety management; trial documentation, tools, and materials; communication, staff training and community engagement/sensitization; financial and administrative hurdles; and more). Ultimately, to reach the successful end of the vaccine trial in this remote Ebola endemic area in the DRC, careful planning, collaboration, and great flexibility and adaptability was often required from all involved partners. Despite the encountered challenges, the vaccine trial discussed in this paper was able to obtain high participant retention rates (i.e., 92% of participants completed the study). We hope that other international teams aspiring to conduct similar trials in remote areas of LMICs can learn from the way our challenges were addressed, mitigations developed, and lessons were learned.
Language
English
Source (journal)
Vaccine / International Society for Vaccines. - Amsterdam
Publication
Amsterdam : 2023
ISSN
0264-410X
DOI
10.1016/J.VACCINE.2023.11.030
Volume/pages
41 :51 (2023) , p. 7587-7597
ISI
001133677600001
Pubmed ID
37993355
Full text (Publisher's DOI)
Full text (open access)
UAntwerpen
Faculty/Department
Research group
Project info
Bringing a prophylactic Ebola vaccine to licensure (EBOVAC3).
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Record
Identifier
Creation 07.12.2023
Last edited 01.02.2024
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