RECRUITING

Bone Marrow and Peripheral Blood Immune Responses Study

Conditions

Influenza Influenza Vaccine Bone Marrow Immune Response

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-10-16

Study Completion:2029-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05616546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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.

Inclusion Criteria

Exclusion 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

* 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.

Contacts and Locations

Study Contact

Jennifer C Truell, MA, MPH

CONTACT

404-778-0014

jennifer.carter.truell@emory.edu

Principal Investigator

Edmund K Waller, MD, PhD

PRINCIPAL_INVESTIGATOR

Emory University

Study Locations (Sites)

Emory University Hospital

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Edmund K Waller, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-16

Study Completion Date2029-12

Study Record Updates

Study Start Date2023-10-16

Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

Influenza Vaccine
Bone Marrow
Immune Response

Additional Relevant MeSH Terms

Influenza