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RecruitingAccepts healthy volunteersPhase 4

Bone Marrow and Peripheral Blood Immune Responses Study

Emory University · with National Institute of Allergy and Infectious Diseases (NIAID) · NCT05616546

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–64 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 4
Target enrollment
90
US sites recruiting
1
Study start
October 16, 2023
Record last updated
January 31, 2024

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Influenza Vaccine

Conditions: Influenza

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Adults unable to consent
  • Women who are pregnant or nursing a child may not take part in this study. If a woman of childbearing potential is enrolled in this study, she and the study doctor must agree on a method of birth control to use throughout the study. Enrollees who think that they may have gotten pregnant during the study must tell the study doctor immediately. Pregnant women will be taken out of the study.
  • Prisoners
  • Cognitively impaired or individuals with impaired decision-making capacity
  • Individuals who are vulnerable to coercion or undue influence (human fetuses, or neonates of uncertain viability or non-viable neonates, minors/children, and cognitively impaired adults) will not be eligible for participation in this study.

Recruiting US locations

  • Emory University Hospital

    Atlanta, GA 30322

    Site contact: Jennifer C. Truell, MA, MPH · 404-778-0014 · jennifer.carter.truell@emory.edu

Study contacts (from the official record)

  • Jennifer C Truell, MA, MPH · 404-778-0014 · jennifer.carter.truell@emory.edu
All vaccine studies in Georgia →
Bone Marrow and Peripheral Blood Immune Responses Study (NCT05616546) | Bored Studies