Clinical Trial

Bone Marrow and Peripheral Blood Immune Responses Study

Recruiting Phase 4
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Summary
The purpose of this study is to evaluate the immune response of the killed flu vaccine in healthy subjects. Participants in this study are considered to be healthy volunteers. Influenza ("Flu") infection carries a risk of serious illness. This is an open label and single arm observational study designed to assess the humoral response to influenza vaccination and the longevity of humoral immunity to influenza vaccination in healthy adults. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study). Participants will donate serial samples of blood and bone marrow aspirate for immunology monitoring. Repeated measurements of humoral immunity will be obtained at 7 days, 28 days, 90 days and at one year post vaccination to assess the magnitude, clonal diversity and persistence of B-cell responses to influenza vaccination.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-11-08; most recent amendment 2024-01-30.
Status change: Not Yet Recruiting → Recruiting 2023-05-31
Trial Details
NCT Number NCT05616546
Lead Sponsor Emory University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Influenza
Enrollment 90 participants
Start Date 2023-10-16
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2024-01-31