Immunology of Ebola Vaccine
An Open-label Interventional Study to Understand and Quantify the Duration of Humoral Immunological Memory to a Single Dose of Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP)
1 other identifier
interventional
30
1 country
2
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 and following vaccination to assess immune responses in the blood, lymph nodes, and bone marrow over multiple time points.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2024
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2023
CompletedFirst Posted
Study publicly available on registry
October 25, 2023
CompletedStudy Start
First participant enrolled
August 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
January 22, 2026
January 1, 2026
3.1 years
October 20, 2023
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ebola-specific Antibody Titers
Antibody titers are examined by direct comparison of antibody titers in the blood. Serum-binding Ebola-specific antibody titers following rVSV∆G-ZEBOV-GP vaccination will be measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Day 29, Day 726
Secondary Outcomes (7)
Frequency of Adverse Events (AEs)
Up to Day 28
Severity of Adverse Events
Up to Day 28
Frequency of Serious Adverse Events
Up to Day 726
Frequency of Adverse Events Related to Fine Needle Aspiration/Biopsy of Lymph Node
Up to Day 726
Severity of Adverse Events Related to Fine Needle Aspiration/Biopsy of Lymph Node
Up to Day 726
- +2 more secondary outcomes
Study Arms (3)
Recombinant Vesicular Stomatitis Vaccine for Ebola
EXPERIMENTALHealthy adults who are at no risk for exposure to Ebola Virus and are not prior recipients of an Ebola vaccine receive a single dose of recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP).
Recombinant Vesicular Stomatitis Vaccine for Ebola and Deuterium Labeled Water for 14 Days
EXPERIMENTALHealthy adults who are at no risk for exposure to Ebola Virus and are not prior recipients of an Ebola vaccine receive a single dose of recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP) plus deuterium labeled water three times daily for 14 days from days 1-15.
Recombinant Vesicular Stomatitis Vaccine for Ebola and Deuterium Labeled Water for 28 Days
EXPERIMENTALHealthy adults who are at no risk for exposure to Ebola Virus and are not prior recipients of an Ebola vaccine receive a single dose of recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP) plus deuterium labeled water three times daily for 28 days from days 57-85.
Interventions
An Emory Investigational Drug Service pharmacist will prepare sterile 50 ml aliquots of D2O with a tamper seal and stored at room temperature. Participants will be asked to drink a pre-measured volume of water three times a day and on days according to their assigned group schedule.
The study vaccine is an FDA-approved recombinant vesicular stomatitis virus (rVSV) expressing the envelope glycoprotein of Ebola virus Zaire (rVSV∆G-ZEBOV-GP). The dose of rVSV∆G-ZEBOV-GP vaccine has been chosen for this study as per package insert recommendations and based on clinical data. Participants receive 1.0 milliliter (mL) of the study vaccine administered intramuscularly in the deltoid muscle of the non-dominant arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Washington University School of Medicinecollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
The Hope Clinic of the Emory Vaccine Center
Decatur, Georgia, 30030, United States
Washington University in St. Louis
St Louis, Missouri, 63130, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadine Rouphael, MD
Emory University
- STUDY CHAIR
Ali Ellebedy, PhD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 20, 2023
First Posted
October 25, 2023
Study Start
August 6, 2024
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will become available for sharing upon publication of results for this study, with no end date.
- Access Criteria
- Data will be available for sharing with anyone who wishes to access the data for any purpose. GenBank sequence records will be made available at https://ftp.ncbi.nih.gov/genbank/ or accessed using NCBI's E-utilities application programming interface (API). SRA sequence records will be made available using the SRA Toolkit API (https://github.com/ncbi/sra-tools/wiki) or on Amazon Web Services and Google Cloud Platform clouds (https://www.ncbi.nlm.nih.gov/sra/docs/sra-cloud/). Upon release, publicly accessible sequence data are searchable by accession number in website interfaces. NCBI also indexes the data to support text-based searches (e.g., by organism name) in websites and APIs.
De-identified data collected during the trial will be submitted to the National Center for Biotechnology Information (NCBI) on its GenBank and Sequence Read Archive (SRA) archives for public release upon publication of the findings of our studies. GenBank is the United States National Institutes of Health genetic sequence database, an annotated collection of all publicly available DNA sequences. SRA is an open access archive of minimally-processed read data from high throughput platforms.