Conducting an Ebola vaccine trial in a remote area of the Democratic Republic of the Congo: Challenges, mitigations, and lessons learned

Vaccine. 2023 Nov 21:S0264-410X(23)01363-4. doi: 10.1016/j.vaccine.2023.11.030. Online ahead of print.ABSTRACTConducting 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 ma...

Source: Vaccine - November 22, 2023 Category: Allergy & Immunology Authors: Ynke Larivi ère Tr ésor Zola Matuvanga Gwen Lemey Bernard Isekah Osang'ir Paul Peter Vermeiren Solange Milolo Rachel Meta Primo Kimbulu Emmanuel Esanga Junior Matangila Jean-Pierre Van Geertruyden Pierre Van Damme Vivi Maketa Hypolite Muhindo-Mavoko Pat Source Type: research