Status:
RECRUITING
Immunology of Ebola Vaccine
Lead Sponsor:
Emory University
Collaborating Sponsors:
Washington University School of Medicine
Merck Sharp & Dohme LLC
Conditions:
Ebola Virus Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this study 30 healthy adult participants will receive a single dose of an Ebola vaccine. Blood samples, fine needle aspirates, core biopsies, and bone marrow aspirates will be collected prior to an...
Detailed Description
Ebolaviruses (EBOV), cause Ebola Virus Disease, a condition characterized primarily by hemorrhagic fevers with remarkably elevated mortality rates. The genus Ebolavirus encompasses five distinct viral...
Eligibility Criteria
Inclusion
- Signed informed consent for study.
- For women of childbearing potential: willing to engage in effective methods of contraception starting at least 28 days prior to vaccination and during the study.
- Willing to minimize blood and body fluid exposure to others (encourage abstinence, and hand hygiene; discourage contact with blood, vomit, feces without personal protective equipment (PPE) for at least 14 days following vaccine administration.
- Willing to forgo blood donation 30 days prior to and for the duration of study participation.
Exclusion
- At risk of travel-related or occupational exposure to Ebola virus such as through laboratory, clinical contact, field work, or in the judgment of the investigator.
- Received any Ebola vaccines or have history of Ebola Virus Disease (EVD).
- Current or previous diagnosis of immunocompromising condition such as human immunodeficiency virus or other immunosuppressive condition by receiving systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to screening (for corticosteroids: ≥ 10mg/day of prednisone or equivalent) or anticipates the need for immunosuppressive treatment at any time during participation in the study.
- Pregnant and/or breastfeeding (must have urine pregnancy test on the day of vaccination and during screening visit)
- Known allergy to any component of the rVSV∆G-ZEBOV-GP vaccine products (VSV, albumin, tris, rice protein).
- History of severe local or systemic reactions to any vaccination.
- Received investigational drug within 5 half-lives or 28 days, whichever is longer, prior to study vaccination.
- Received or intends to receive vaccines within 28 days prior to or following study vaccination.
- Received immunoglobulins and/or any blood products within 120 days prior to study vaccination.
- Clinical evidence of systemic infection or other acute intercurrent illness (e.g. oral temp \>38°C or \> 100.4°F) less than 72 hours prior to study vaccination.
- Currently has symptomatic, acute, or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator.
- History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions, or occupational conditions that in the opinion of the investigator would preclude compliance with the study.
- Any condition that would limit the ability of the participant to meet protocol requirements or would place the participant at unreasonable risk in the opinion of the investigator.
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06100913
Start Date
August 6 2024
End Date
August 31 2026
Last Update
August 22 2025
Active Locations (2)
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1
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, United States, 30030
2
Washington University in St. Louis
St Louis, Missouri, United States, 63130