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

Recruiting Phase 3 Interventional Study
Ebola Virus Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 50
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
624 (estimated)
Sponsor
Institute of Tropical Medicine, Belgium · Other
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Subjects who received either the Ervebo® vaccine (MSD), or the full Zabdeno, Mvabea® vaccine regimen (J\&J) more than 4 months prior to recruitment * Subjects between 18 and 50 years of age at time of randomization * Subject must be willing and able to provide informed consent…
Contacts

Wim Adriaensen, Prof.

+32(0)33455909

wadriaensen@itg.be

CONTACT

Selien Oostvogels Oostvogels

soostvogels@itg.be

CONTACT