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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
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Primary completion date: Oct 2025 to Oct 2026
    • Start date changed from estimate of Oct 2024 to Feb 25, 2025
    • Site details revised at 2 of 2 sites
    v4
  2. Re-verified, no change to tracked fieldsv3
  3. Primary completion date: Mar 2025 to Oct 2025v2 Show 5 more changesShow less
    • Start date: Mar 2024 to Oct 2024
    • Primary endpoint revised
    • Study completion date: Mar 2026 to Oct 2026
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints revised (14)
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06126822
Lead Sponsor Institute of Tropical Medicine, Belgium
Collaborators: Institut National pour la Recherche Biomedicale (INRB)
Conditions
(from sponsor)		 Ebola Virus Disease
Related terms Hemorrhagic Fever, Ebola
Enrollment 624 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov