Immunology of Ebola Vaccine
Ebola Virus Disease
About this trial
This is an interventional basic science trial for Ebola Virus Disease focused on measuring vaccine, vaccination, immune response
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.
Sites / Locations
- The Hope Clinic of the Emory Vaccine Center
Arms of the Study
Arm 1
Experimental
Recombinant Vesicular Stomatitis Vaccine for Ebola (rVSV∆G-ZEBOV-GP)
Healthy 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).