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RECRUITING
NCT06126822
PHASE3

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

Sponsor: Institute of Tropical Medicine, Belgium

View on ClinicalTrials.gov

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.

Official title: 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: a Mix-and-match Phase II RCT

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

624

Start Date

2025-02-25

Completion Date

2026-10

Last Updated

2025-03-18

Healthy Volunteers

Yes

Interventions

DRUG

Zabdeno® booster

A single Zabdeno® booster vaccination

DRUG

Ervebo® booster

A single Ervebo® booster vaccination

Locations (2)

Institut National de Recherche Biomédicale (INRB)

Goma, Democratic Republic of the Congo

Institut National de Recherche Biomédicale (INRB)

Kinshasa, Democratic Republic of the Congo