Longitudinal Analysis of Bone Marrow and Peripheral Blood Immune Responses to Influenza Vaccination in a Healthy Adult Cohort

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: t
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• All genders, races and ethnic groups (inclusive of women and minorities) are eligible for this trial, as influenza and the associated range of clinical issues accompanying influenza infection can impact people of all genders, races and ethnic groups. It is anticipated that the distribution of study participants will be diverse with regard to these demographics.

• Adults able to provide consent on their own

• Healthy adults

Locations
United States
Georgia
Emory University Hospital
RECRUITING
Atlanta
Contact Information
Primary
Jennifer C Truell, MA, MPH
jennifer.carter.truell@emory.edu
404-778-0014
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2029-12
Participants
Target number of participants: 90
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Leads: Emory University

This content was sourced from clinicaltrials.gov

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