De Bie, Jessie

Esanga, Emmanuel

Larivi\ue8re, Ynke

Lemey, Gwen

Maketa, Vivi

Matangila, Junior

Matuvanga, Tresor Zola

Meta, Rachel

Milolo, Solange

Mitashi, Patrick

Muhindo-Mavoko, Hypolite

Thys, S\ue9verine

van Damme, Pierre

Van geertruyden, Jean-Pierre

Vermeiren, Peter

Zola Matuvanga, Tr\ue9sor

Abstract: 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

Institutional Repository Universiteit Antwerpen

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

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

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Institutional Repository Universiteit Antwerpen