Actively Recruiting

Phase 4
Age: 18Years - 64Years
All Genders
Healthy Volunteers
ID05616546

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

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

90

Participants Needed

1

Research Sites

N/A

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

Researchers are studying how the immune system responds to the seasonal flu vaccine in healthy adults aged 18 to 64. This study aims to understand the strength, variety, and duration of the body's immune response after receiving the inactivated flu vaccine. The research is important because flu infection can cause serious illness, and learning about immune responses may help improve future vaccines. Participants will receive one dose of an FDA-approved seasonal flu vaccine through an injection in the arm. The study is open-label and observational with no placebo or comparison group. Volunteers can participate for up to three consecutive years if they continue to meet eligibility criteria and agree to re-consent each year. The study lasts up to one year per participant, with blood and bone marrow samples collected at multiple time points after vaccination. During their participation, volunteers will have blood and bone marrow samples taken before vaccination and at 7, 28, 90, and 365 days afterward. These samples will help researchers measure changes in B-cell responses, which are part of the immune system's defense. Participants will be monitored for the persistence and diversity of these immune responses. The study will last seven years in total, enrolling up to 90 healthy volunteers, with opportunities to re-enroll yearly if eligible.

CONDITIONS

Brief 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
  • Healthy adults able to provide consent on their own
Not Eligible

You will not qualify if you...

  • Adults unable to provide consent
  • Women who are pregnant or nursing a child
  • Prisoners
  • Individuals with cognitive impairment or impaired decision-making capacity
  • Vulnerable individuals such as human fetuses, neonates of uncertain viability or non-viable neonates, minors, and cognitively impaired adults

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a single dose of the FDA-approved seasonal inactivated influenza vaccine via injection.

1 vaccination visit (in-person)

Monitoring

Duration - Up to 1 year

Participants are observed to evaluate immune responses to the flu vaccine over time by collecting blood and bone marrow samples.

5 visits on Days 0, 7, 28, 90, and 365 for blood samples; bone marrow samples collected on Days 0, 28, and 365

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

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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