Status:
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
Lead Sponsor:
Institute of Tropical Medicine, Belgium
Collaborating Sponsors:
Institut National pour la Recherche Biomedicale (INRB)
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
The aim of this randomized controlled with four arms is to investigate whether individuals previously vaccinated with Zabdeno/Mvabea® or Ervebo® vaccine schedules against Ebola virus can be safely and...
Eligibility Criteria
Inclusion
- 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
- The subject must be in possession of an identification card (or other identification document)
- Agreement to refrain from blood donation and other vaccinations 30 days after booster vaccination
- Agreement to share and discuss participant's medical history, medical records and concomitant medications when relevant
Exclusion
- Participants who previously experienced active Ebola Virus Disease (EVD)
- Receipt of any vaccine (licensed or experimental) within 30 days prior to recruitment
- Receipt of an additional booster dose of either Ervebo®, Zabdeno®, or any experimental Ebola vaccine
- Incorrect or incomplete primary vaccination scheme with the Zabdeno, Mvabea® (J\&J) vaccine
- Administration of immunoglobulins and/or any blood products within three months prior to recruitment.
- Fever (\>38°C) within last 24 hours prior to recruitment.
- Any confirmed or suspected immunosuppressive or immunodeficient state (incl. cancer and HIV); asplenia; recurrent severe infections and use of immunosuppressant medication within the last 6 months, except topical or short-term oral steroids.
- Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)
- History of anaphylaxis, allergic disease or reactions to any component of the study vaccines
- History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture
- History of any thrombotic disorder, thrombocytopenia, thrombotic thrombocytopenia syndrome (TTP), or heparin-induced thrombocytopenia and thrombosis (HITT)
- Any other significant disease, disorder, planned surgery, or finding which may significantly affect the ability of the volunteer to participate in the study or impair interpretation of the study data
- Suspected or known alcohol or drug dependency
- Subject is not readily available by telephone, email or physical address
- The non-vaccinated control group will also adhere to all the above in- and exclusion criteria, with exemption of:
- Agreement to refrain from blood donation and other vaccinations 30 days after study vaccination
- Subjects who received either the Ervebo® vaccine, or the full Zabdeno, Mvabea® vaccine regimen more than 4 months prior to recruitment
- The latter is rather introduced as an additional exclusion criteria:
- Subjects who received either the Ervebo® vaccine or the full Zabdeno, Mvabea® vaccine regimen
Key Trial Info
Start Date :
February 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
624 Patients enrolled
Trial Details
Trial ID
NCT06126822
Start Date
February 25 2025
End Date
October 1 2026
Last Update
March 18 2025
Active Locations (2)
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1
Institut National de Recherche Biomédicale (INRB)
Goma, Democratic Republic of the Congo
2
Institut National de Recherche Biomédicale (INRB)
Kinshasa, Democratic Republic of the Congo