Actively Recruiting
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
Led by Institute of Tropical Medicine, Belgium · Updated on 2025-03-18
624
Participants Needed
2
Research Sites
83 weeks
Total Duration
On this page
Sponsors
I
Institute of Tropical Medicine, Belgium
Lead Sponsor
I
Institut National pour la Recherche Biomedicale (INRB)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Received either Ervebo4 or full Zabdeno/Mvabea4 vaccine regimen more than 4 months before recruitment
- Aged between 18 and 50 years at randomization
- Willing and able to provide informed consent
- Possess an identification card or other ID document
- Agree to avoid blood donation and other vaccinations for 30 days after booster
- Agree to share medical history, records, and current medications when relevant
You will not qualify if you...
- Previous active Ebola Virus Disease
- Received any vaccine (licensed or experimental) within 30 days before recruitment
- Received an additional booster dose of Ervebo4, Zabdeno4, or any experimental Ebola vaccine
- Incorrect or incomplete primary Zabdeno/Mvabea4 vaccination
- Received immunoglobulins or blood products within 3 months before recruitment
- Fever above 386C in the 24 hours before recruitment
- Confirmed or suspected immunosuppressive or immunodeficient conditions, including cancer, HIV, asplenia, severe infections, or recent immunosuppressant use (except topical or short-term oral steroids)
- Severe or uncontrolled cardiovascular, respiratory, gastrointestinal, liver, kidney, endocrine, or neurological diseases (mild/moderate well-controlled allowed)
- History of anaphylaxis or allergic reaction to any vaccine component
- History of bleeding disorders or significant bleeding/bruising after injections or blood draws
- History of thrombotic disorders such as thrombocytopenia, TTP, or HITT
- Any other significant illness, surgery, or condition affecting study participation or data interpretation
- Known or suspected alcohol or drug dependency
- Not easily reachable by phone, email, or physical address
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institut National de Recherche Biomédicale (INRB)
Goma, Democratic Republic of the Congo
Not Yet Recruiting
2
Institut National de Recherche Biomédicale (INRB)
Kinshasa, Democratic Republic of the Congo
Actively Recruiting
Research Team
W
Wim Adriaensen, Prof.
CONTACT
S
Selien Oostvogels Oostvogels
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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