Bone Marrow and Peripheral Blood Immune Responses Study

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05616546
Phase
PHASE4
Status
Recruiting
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Conditions

  • Influenza

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • Influenza Vaccine — BIOLOGICAL
    The vaccine used in this study will be a licensed seasonal inactivated influenza vaccine for intramuscular injection that is approved by the FDA. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study).

Study Details

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.

Key Dates

Start date
Oct 16, 2023
Status verified
Jan 2024
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Influenza Vaccine
    Healthy male and female individuals aged 18-64 years will be eligible to participate in this study. Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers

Primary Outcome Measure

Changes in clonal diversity of B-Cell response to Influenza in blood [ Time Frame: Study Days: 0, 7, 28, 90, 365 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Jennifer C. Truell, MA, MPH
[email protected]
404-778-0014

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Emory University Hospital· Atlanta, GA

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