Actively Recruiting

Phase 4
Age: 18Years - 64Years
All Genders
Healthy Volunteers
NCT05616546

Bone Marrow and Peripheral Blood Immune Responses Study

Led by Emory University · Updated on 2024-01-31

90

Participants Needed

1

Research Sites

319 weeks

Total Duration

On this page

Sponsors

E

Emory University

Lead Sponsor

N

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Bone Marrow and Peripheral Blood Immune Responses Study

Who Can Participate

Age: 18Years - 64Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 64 years
  • All genders, races, and ethnic groups are eligible
  • Able to provide informed consent independently
  • Healthy adults
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Pregnant or nursing women
  • Prisoners
  • Cognitively impaired individuals or those with impaired decision-making capacity
  • Vulnerable populations such as human fetuses, neonates of uncertain viability, non-viable neonates, minors/children, and cognitively impaired adults

AI-Screening

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Trial Site Locations

Total: 1 location

1

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

J

Jennifer C Truell, MA, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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