Immunology of Ebola Vaccine

Launched by EMORY UNIVERSITY · Oct 20, 2023

Keywords

ClinConnect Summary

This clinical trial is studying an Ebola vaccine to see how it affects the immune system. The trial involves 30 healthy adults who will receive a single dose of the vaccine. Researchers will collect blood samples and other tissues before and after vaccination to learn how the body responds over time. This information will help scientists understand how well the vaccine works in building immunity against the Ebola virus.

To participate, individuals must be between 18 and 50 years old, agree to follow specific health guidelines, and be willing to avoid blood donation for a period after vaccination. They should not have a history of Ebola exposure, certain health conditions, or be pregnant. Participants can expect to undergo several medical assessments and will need to be cautious about avoiding contact with bodily fluids for a short time after receiving the vaccine. This trial is a crucial step in developing a safe and effective vaccine for Ebola virus disease.

Gender

ALL

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.