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)

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
United States
Georgia
The Hope Clinic of the Emory Vaccine Center
RECRUITING
Decatur
Missouri
Washington University in St. Louis
RECRUITING
St Louis
Contact Information
Primary
Nadine Rouphael, MD
nroupha@emory.edu
404-712-1435
Time Frame
Start Date: 2024-08-06
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 30
Treatments
Experimental: Recombinant Vesicular Stomatitis Vaccine for Ebola
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).
Experimental: Recombinant Vesicular Stomatitis Vaccine for Ebola and Deuterium Labeled Water for 14 Days
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) plus deuterium labeled water three times daily for 14 days from days 1-15.
Experimental: Recombinant Vesicular Stomatitis Vaccine for Ebola and Deuterium Labeled Water for 28 Days
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) plus deuterium labeled water three times daily for 28 days from days 57-85.
Sponsors
Collaborators: Washington University School of Medicine, Merck Sharp & Dohme LLC
Leads: Emory University

This content was sourced from clinicaltrials.gov