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

• Published in: Vaccine Vol. 40; no. 25; pp. 3470 - 3480
• Main Authors: Zola Matuvanga, Trésor, Larivière, Ynke, Lemey, Gwen, De Bie, Jessie, Milolo, Solange, Meta, Rachel, Esanga, Emmanuel, Vermeiren, Paul Peter, Thys, Séverine, Van geertruyden, Jean-Pierre, Van Damme, Pierre, Maketa, Vivi, Matangila, Junior, Mitashi, Patrick, Muhindo-Mavoko, Hypolite
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 31.05.2022; Elsevier Limited
• Subjects: Challenges; Climatic conditions; Clinical trials; Clinical Trials as Topic; Community involvement; Community participation; Consortia; COVID-19; Democratic Republic of the Congo; Democratic Republic of the Congo - epidemiology; Disease Outbreaks - prevention & control; Drug dosages; Ebola Vaccines; Ebola virus; Ebola virus disease; Ebolavirus; Endemic; Epidemics; Ethics; Experiences; Health care providers; Hemorrhagic Fever, Ebola - epidemiology; Hemorrhagic Fever, Ebola - prevention & control; Humans; Immunogenicity; Infectious diseases; Internet access; Lessons learned; Logistics; Mitigations; Mortality; Past activities; Pharmaceutical industry; Presidential elections; Vaccine trial; Vaccines; Viral diseases; Democratic Republic of the Congo; Congo-Democratic Republic of Congo; Africa; Lessons learned; Challenges; Mitigations; Experiences; Health care providers; Democratic Republic of the Congo; Vaccine trial; Past activities; Endemic; Ebola virus disease
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2022.04.094

•Clinical trial regulations are becoming increasingly complex and demanding for low- and middle-income countries (LMICs)•International collaboration based on equal partnership can help LMICs perform high quality vaccine trials.•Maintaining acquired capacity while conducting clinical trials in LMICs is key and needs long term international support.•Transparency of lessons learned during clinical trials can assist for a more efficient conduct of trials.•This article describes the challenges, mitigations and lessons learned during the setup of a vaccine trial in a LMIC. Since the largest Ebola outbreak in West Africa (2013–2016) highlighted the potential threat of the Ebola virus to the world, several vaccines have been under development by different pharmaceutical companies. To obtain vaccine licensure, vaccine trials assessing the safety, immunogenicity and efficacy of new vaccines among different populations (e.g. different in age, gender, race, and ethnicity) play a crucial role. However, while this deadly disease mainly affects Central and West Africa, clinical trial regulations are becoming increasingly complex and consequently more expensive, influencing the affected low- and middle-income countries (LMICs) in performing high quality clinical trials. Consequently, the completion of such trials in LMICs takes more time and vaccines and drugs take longer to be licensed. To overcome some of the obstacles faced, the EBOVAC3 consortium, funded by the European Union’s Innovative Medicines Initiative and the Coalition for Epidemic Preparedness Innovations, enabled high quality vaccine trials in Central and West Africa through extensive North-South collaborations. In this article, the encountered challenges, mitigations, recommendations and lessons learned from setting-up an Ebola vaccine trial in a remote area of the Democratic Republic of Congo are presented. These challenges are grouped into eight categories: (1) Regulatory, political and ethical, (2) Trial documents, (3) International collaborations, (4) Local trial staff, (5) Community engagement and sensitization, (6) Logistics, (7) Remoteness and climate conditions, (8) Financial. By sharing the encountered challenges, implemented mitigations and lessons learned for each of these categories, we hope to prepare and inform other researchers aspiring a well-functioning clinical trial unit in similar remote settings in LMICs. ClinicalTrials.gov identifier: NCT04186000.