Pilot Study Evaluating the Impact of Delay Between Administration of Inmazeb Administration and Vaccination by Ervebo on Vaccine Immune Response on Healthy Volunteers
Ebola Virus Disease
About this trial
This is an interventional prevention trial for Ebola Virus Disease focused on measuring Post Exposure Prophylaxis, Ebola vaccine
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Research center of Landreah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Experimental
Experimental
Experimental
Experimental
Single vaccination
Simoultaneous vaccination
Early vaccination
Intermediate vaccination
Late vaccination
The control arm (vaccination alone) will serve as a comparator of vaccine response. r-VSV-ZEBOV vaccine will be administered at inclusion (D0)
Mabs and r-VSV-ZEBOV vaccine will be administered the same day, at inclusion (D0), one hours appart
Mabs are administered at inclusion (D0) and r-VSV-ZEBOV vaccine 3 weeks later
Mabs are administered at inclusion (D0) and r-VSV-ZEBOV vaccine 6 weeks later
Mabs are administered at inclusion (D0) and r-VSV-ZEBOV vaccine 12 weeks later