Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive a single dose of the FDA-approved seasonal inactivated influenza vaccine via injection.
1 vaccination visit (in-person)
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
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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