Clinical Trial

Safety and Immunogenicity of Ervebo® and Zabdeno® Booster Vaccines Against Ebola Virus Following Previous Vaccination with the Zabdeno/Mvabea® or Ervebo® Vaccine Schedules in DRC

Study acronym: EBO-BOOST
Recruiting Phase 3
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Summary
The goal of this randomized controlled trial is to investigate whether individuals in DRC previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and adequately boosted with homologous or heterologous vaccine schedules. Participants will be randomized to receive either a homologous or heterologous vaccine schedule and will be asked to come to the clinic at prespecified timepoints over a period of 6 months to collect blood samples for comparison of immunological responses against Ebola virus between both schedules. Safety and tolerability of the vaccines will be evaluated by recording Adverse Events (AE's) and grading physical and vital signs evaluations.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-11-06; most recent amendment 2025-03-13.
Status change: Not Yet Recruiting → Recruiting 2025-03-13
Trial Details
NCT Number NCT06126822
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Institut National pour la Recherche Biomedicale (INRB)
Conditions Ebola Virus Disease
Enrollment 624 participants
Start Date 2025-02-25
Primary Completion 2026-10 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-03-18