drugset / Trial / NCT06126822
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
Phase 3
Recruiting
624 enrolled
Institute of Tropical Medicine, Belgium
Institut National pour la Recherche Biomedicale (INRB) · collab
RandomizedParallel-groupSingle-blindPrevention
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.
Timeline
- Start
- 2025-02-25
- Primary completion
- 2026-10
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ADENOVIRUS TYPE 26 ENCODING EBOLA VIRUS GLYCOPROTEIN | Vaccine | 0.5 ml | Intramuscular |
| Subject | Ervebo | Vaccine | 1 ml | Intramuscular |