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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

NCT06126822 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 624

Last updated 2025-03-18

No results posted yet for this study

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.

Conditions

  • Ebola Virus Disease

Interventions

DRUG

Zabdeno® booster

A single Zabdeno® booster vaccination

DRUG

Ervebo® booster

A single Ervebo® booster vaccination

Sponsors & Collaborators

  • Institut National pour la Recherche Biomedicale (INRB)

    collaborator UNKNOWN

  • Institute of Tropical Medicine, Belgium

    lead OTHER

Principal Investigators

  • Wim Adriaensen, Prof. · Institute of Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Democratic Republic of the Congo

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06126822 on ClinicalTrials.gov