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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
Sponsor: Institute of Tropical Medicine, Belgium
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
Conditions
Interventions
Zabdeno® booster
A single Zabdeno® booster vaccination
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