Second phase of Ebola vaccination trial in DR Congo

An Ebola vaccination trial focusing on health care providers in the Democratic Republic of the Congo (DR Congo) was kick-started at the end of 2019. As of 30 November 2020, the next phase of this trial officially began and all participants return to the trial site.

Over the years, DR Congo has experienced 11 Ebola outbreaks; the latest of these was declared over in November 2020. In 2018, Prof. Van Damme, head of the Centre for the Evaluation of Vaccination, and Prof. Van geertruyden, head of Global Health Institute, joined hands with the department of tropical medicine of the Université de Kinshasa (UNIKIN) and Janssen Vaccines & Prevention B.V. to conduct a clinical trial to assess the feasibility and gather safety and immunogenicity data on the administered vaccines in approximately 700 Health Care Providers in Boende, an Ebola epidemic prone region in DR Congo. It has been suggested that the vaccination of Health Care Providers has significant potential in reducing the scale and duration of outbreaks.

On December 18^th 2019, the first participant screening and vaccination started. Mid-February 2020, full recruitment of the study population was reached. In this first phase of the study, participants received the first and second doses of the heterologous vaccine regimen developed by Janssen Vaccines & Prevention B.V. in partnership with Bavarian Nordic A/S.

At the end of November 2020, a delegation of the UAntwerp team, together with the implementing partner UNIKIN, traveled to Boende to start up the next phase in the project. During this visit, all locally recruited staff involved in the different aspects of the trial (medical, nursing, data management, laboratories, etc.) received a refresher course on the trial proceedings, Good Clinical Practices, Standard Operational Practices, etc. As of 30 November, and going up to mid-February 2021, all enrolled participants are expected to return to the trial site for a third “booster” vaccination and/or a blood sample for safety follow up and immunogenicity analysis. The goal is to further document this Ebola vaccine regimen.

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 800176. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme, EFPIA and CEPI.