Ebola vaccine immune response assessment

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)

This study tests how well a new Ebola vaccine works in healthy adults by looking at their immune responses after getting the shot.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Emory University (Academic / other)
• Drugs / interventions: prednisone
• Locations: 2 sites (Decatur, Georgia and 1 other locations)
• Trial ID: NCT06100913 on ClinicalTrials.gov

What this trial studies

This study involves administering a single dose of an Ebola vaccine to 30 healthy adult participants. Researchers will collect blood samples, fine needle aspirates, core biopsies, and bone marrow aspirates before and after vaccination to evaluate the immune responses in various body tissues over multiple time points. The goal is to understand how the vaccine stimulates the immune system against the Ebola virus. This research is crucial for developing effective vaccines against Ebola Virus Disease, which has a high mortality rate.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults who can provide informed consent and meet specific eligibility criteria.

Not a fit: Patients who have a history of Ebola Virus Disease or are at risk of exposure to the virus may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved vaccine strategies that enhance immune responses against Ebola Virus Disease.

How similar studies have performed: Other studies have shown promise in vaccine development for Ebola, indicating that this approach has potential based on previous findings.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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.

Where this trial is running

Decatur, Georgia and 1 other locations

• The Hope Clinic of the Emory Vaccine Center — Decatur, Georgia, United States (Recruiting)
• Washington University in St. Louis — Saint Louis, Missouri, United States (Recruiting)

Study contacts

• Principal investigator: Nadine Rouphael, MD — Emory University
• Study coordinator: Nadine Rouphael, MD

Conditions Ebola Virus Disease; vaccine; vaccination; immune response