Status:
UNKNOWN
Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers
Lead Sponsor:
ANRS, Emerging Infectious Diseases
Collaborating Sponsors:
Alliance for International Medical Action
University of Bordeaux
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Ebola virus disease (EVD) is emerging regularly in various African countries for various reasons: during contact with mortal remains, during an unsafe burial or following the viral dissemination aroun...
Detailed Description
Ebola virus disease (EVD) is emerging regularly in various African countries for various reasons: during contact with mortal remains, during an unsafe burial or following the viral dissemination aroun...
Eligibility Criteria
Inclusion
- Available for the duration of the protocol follow-up;
- Consent to participate ;
- Agreed not to participate in another clinical research study until the end of the trial follow-up.
Exclusion
- Prior history of EVD (self-reported);
- Previous vaccination with r-VSV-ZEBOV or any other Ebola vaccine (self-reported);
- Previous administration of Ebola antibody-based PEP;
- HIV-1 and/or 2 positive serology;
- Pregnant women (positive pregnancy test);
- To the opinion of the investigator, any clinically significant acute/chronic condition that would limit the participant's ability to meet the requirements of the study protocol;
- Immunosuppressive drugs;
- Participation in another clinical research study within the last 30 days;
- Allergy to any component of the vaccine or Mabs;
- Any other reason that, at the investigator's discretion, would compromise the participant's safety and cooperation in the trial.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05202288
Start Date
March 1 2022
End Date
March 1 2023
Last Update
January 21 2022
Active Locations (1)
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1
Research center of Landreah
Conakry, Guinea