RECRUITING

Immunology of Ebola Vaccine

Conditions

Ebola Virus Disease vaccine vaccination immune response

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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)

Quick Facts

Study Start:2024-08-06

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06100913

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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 until 56 days following vaccination.	* 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). * 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.

Inclusion Criteria

Exclusion Criteria

* 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 until 56 days following vaccination.

* 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).
* 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.

Contacts and Locations

Study Contact

Nadine Rouphael, MD

CONTACT

404-712-1435

nroupha@emory.edu

Principal Investigator

Nadine Rouphael, MD

PRINCIPAL_INVESTIGATOR

Emory University

Ali Ellebedy, PhD

STUDY_CHAIR

Washington University School of Medicine

Study Locations (Sites)

The Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030

United States

Washington University in St. Louis

Saint Louis, Missouri, 63130

United States

Collaborators and Investigators

Sponsor: Emory University

Nadine Rouphael, MD, PRINCIPAL_INVESTIGATOR, Emory University
Ali Ellebedy, PhD, STUDY_CHAIR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-06

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-08-06

Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

vaccine
vaccination
immune response

Additional Relevant MeSH Terms

Ebola Virus Disease