Health Care Providers Study – EBL2007

The EBL2007 clinical trial is an Open-label Phase 2 study set up to evaluate the immunogenicity and safety of the Ebola vaccine regimen in health care providers, in Boende, the Democratic Republic of the Congo (DRC).

Rationale and Experimental Design

This Phase 2 study aims to improve preparedness for future Ebola outbreaks by vaccination of a well-known population at risk, i.e., a cohort of health care providers (such as primary, emergency, and community health care workers) who may be exposed to Ebola in the event of a future outbreak in the DRC. This study will enhance the immunogenicity database by investigating the kinetics of the humoral immune response. The study will assess safety (serious adverse events) following the administration of a heterologous vaccine regimen with Ad26.ZEBOV as the first dose, followed by MVA-BN-Filo as the second dose administered 56 days later (Day 57). Additionally, after randomization (1:1), a booster vaccination with Ad26.ZEBOV will be given at one year post first dose or two years post first dose.

Timeline

Tentative timeline of the EBL2007 clinical study. From left to right: recruitment & dose 1 vaccinations at day 1 (18 Dec 2019 – 8 Feb 2020), dose 2 vaccinations at day 57 (11 Feb – 2 Apr 2020), immunogenicity and safety follow-up at day 78 (2 Mar – 25 Apr 2020), booster vaccination at year 1 and immunogenicity and safety follow-up of randomized group 1 (Nov 2020 – Mar 2021), booster vaccination at year 2 and immunogenicity and safety follow-up of randomized group 2 (Nov 2021 – Mar 2022).

Study Activities

Partners in the EBL2007 study include:

  • University of Antwerp 
  • University of Kinshasa 
  • Janssen Vaccines & Prevention B.V. 
  • Coalition for Epidemic Preparedness Innovations
These projects have received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOVAC3 (grant nr. 800176), EBOMAN (grant nr. 115850) and EBODAC (grant nr. 115847). This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and European Federation of Pharmaceutical Industries and Associations (EFPIA).
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