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Bone Marrow and Peripheral Blood Immune Responses Study

StatusRecruiting
PhasePhase 4
Started2023-10-16
View on ClinicalTrials.gov ↗

Amendment history

2024-01-30
Study Status, Eligibility, Contacts/Locations v7
Start dateestimated 2023-11→confirmed 2023-10-16
2023-10-11
Study Status, Contacts/Locations v6
Start date2023-09→2023-11
Study sitescontacts updated at 1 of 1 site
2023-09-01
Study Status, Arms and Interventions, Eligibility v5
Re-verified, no change to tracked fields
2023-08-02
Study Status v4
Start date2023-05→2023-09
2023-05-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2023-04→2023-05
Study sitesdetails revised at 1 of 1 site
Show 2 earlier versions
2023-03-17
Study Status v2
Primary completion date2029-09→2029-12
Completion date2029-09→2029-12
Start date2023-01→2023-04
2022-12-07
Study Status v1
Primary completion date2029-06→2029-09
Completion date2029-06→2029-09
Start date2022-11→2023-01
2022-11-08
Original filing
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.
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