search
Back to results

Bone Marrow and Peripheral Blood Immune Responses Study

Primary Purpose

Influenza

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Influenza Vaccine
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza focused on measuring Influenza Vaccine, Bone Marrow, Immune Response

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Influenza Vaccine

Arm Description

Healthy male and female individuals aged 18-64 years will be eligible to participate in this study. Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers

Outcomes

Primary Outcome Measures

Changes in clonal diversity of B-Cell response to Influenza in blood
Blood samples will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Changes in clonal diversity of B-Cell response to Influenza in bone marrow
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Changes in magnitude of B-Cell response to Influenza in blood
Blood samples will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Magnitude of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Changes in magnitude of B-Cell response to Influenza in bone marrow
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Magnitude of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Changes in persistence of B-Cell response to Influenza in blood
Blood samples will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Persistence of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes. Persistence of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Changes in Bone marrow persistence of B-Cell response to Influenza
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Persistence of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.

Secondary Outcome Measures

Full Information

First Posted
October 21, 2022
Last Updated
October 11, 2023
Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
search

1. Study Identification

Unique Protocol Identification Number
NCT05616546
Brief Title
Bone Marrow and Peripheral Blood Immune Responses Study
Official Title
Longitudinal Analysis of Bone Marrow and Peripheral Blood Immune Responses to Influenza Vaccination in a Healthy Adult Cohort
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2029 (Anticipated)
Study Completion Date
December 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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. The immune system is the body's defense against all kinds of infections and foreign invaders. The flu vaccine is a dose of killed (inactivated) flu virus. The immune system then builds protective responses against the flu virus. These responses help attack and kill the virus. One may not get sick at all, or may have a much shorter or milder illness. The killed flu vaccine is made from a killed influenza virus that has been split apart and modified in such a way as to not be able to grow at all in humans. The killed flu vaccine is given via an injection into your arm. The purpose of this research study is to test the immune response to a vaccination for influenza (the "flu"). Participants will be given one dose of an FDA-approved influenza vaccine. The flu vaccine used in this study is the same seasonal flu vaccine that is approved by the government for this year. The study will measure immune response to the seasonal flu vaccine by measuring the immune response in the blood and bone marrow over a period of time, for up to 1 year post (after) vaccination. Researchers expect to see a change in the immune system in response to the flu vaccination. This response will be evaluated by comparing data obtained before flu vaccination to data collected at specified time points (0, 7, 28, 90, and 365 days) after the administration of the flu vaccine. It is possible that by measuring these differences, especially in the bone marrow, clinicians can better understand how the body responds to flu vaccination and how long the immunity lasts. This is important because it could help lead to the creation of more effective flu vaccines in the future. Up to 90 healthy volunteers will be enrolled into the study. Subjects chosen to participate in this study will be healthy volunteers who are eligible to receive the flu vaccine. An individual's study participation will last for up to 365 days, or 1 year. Subjects who complete the study will be given the option to re-enroll if they meet enrollment criteria. The duration for this study is seven years. This single site study will take place at Emory University. As this is a healthy volunteers study, flyers, social media posts, and electronic newsletter advertisements will be used to recruit participants for this study. Interested individuals can contact the study team to determine eligibility. We will not request any waivers of consent. Participants will be asked, as part of the informed consent process, whether or not they agree to have their specimens used only for future research. This decision can be changed at any time by the participant without penalty. Participants who agree to take part in this study will have specimens collected for antibody determination and viral typing. Each specimen will be labeled only with a unique tracking number to protect participant's confidentiality. These samples will not be used for genetic (DNA) studies and will be stored in a coded manner indefinitely.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza Vaccine, Bone Marrow, Immune Response

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Influenza Vaccine
Arm Type
Experimental
Arm Description
Healthy male and female individuals aged 18-64 years will be eligible to participate in this study. Subjects will be offered the opportunity to participate in the study for up to 3 consecutive years, provided eligibility criteria are met each year. Subjects will be re-screened to verify continued eligibility and re-consented prior to subsequent participation and will receive new subject identifiers
Intervention Type
Biological
Intervention Name(s)
Influenza Vaccine
Intervention Description
The vaccine used in this study will be a licensed seasonal inactivated influenza vaccine for intramuscular injection that is approved by the FDA. Enrolled subjects will receive licensed seasonal inactivated influenza vaccine (administered as a part of the study).
Primary Outcome Measure Information:
Title
Changes in clonal diversity of B-Cell response to Influenza in blood
Description
Blood samples will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Time Frame
Study Days: 0, 7, 28, 90, 365
Title
Changes in clonal diversity of B-Cell response to Influenza in bone marrow
Description
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Clonal diversity of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Time Frame
Study Days 0, 28, 365
Title
Changes in magnitude of B-Cell response to Influenza in blood
Description
Blood samples will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Magnitude of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Time Frame
Study Days: 0, 7, 28, 90, 365
Title
Changes in magnitude of B-Cell response to Influenza in bone marrow
Description
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Magnitude of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Time Frame
Study Days 0, 28, 365
Title
Changes in persistence of B-Cell response to Influenza in blood
Description
Blood samples will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) of Emory University by a skilled clinical research nurse or phlebotomist. Blood samples will be drawn and stored in 8ml CPT tubes. These samples will be maintained at room temperature until they are transported to the laboratory. Persistence of B-Cell response to Influenza will be measured on study days 0, 7, 28, 90, and 365, and compared for changes. Persistence of B-Cell response to Influenza in blood will be measured on study days 0, 7, 28, 90, and 365, and compared for changes.
Time Frame
Study Days: 0, 7, 28, 90, 365
Title
Changes in Bone marrow persistence of B-Cell response to Influenza
Description
Bone marrow aspirate specimens will be drawn, labeled, and logged at the Georgia Clinical & Translational Science Alliance (CTSA) by the Principal Investigator. These samples will be collected in 10 ml sodium heparin tubes and labeled with coded subject information. They will be maintained at room temperature until they are transported to the laboratory. Persistence of B-Cell response to Influenza in bone marrow, will be measured on study days 0, 28, and 365, and compared for changes.
Time Frame
Study Days 0, 28, 365

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer K Truell, MA, MPH
Phone
404-778-0014
Email
jennifer.carter.truell@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmund K Waller, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer C. Truell, MA, MPH
Phone
404-778-0014
Email
jennifer.carter.truell@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified genomic data and de-identified health information will be shared
IPD Sharing Time Frame
Immediately following publication, no end date
IPD Sharing Access Criteria
Researchers who apply for and receive permission to use the information for a specific research project, regarding any research question by controlled-access databases

Learn more about this trial

Bone Marrow and Peripheral Blood Immune Responses Study

We'll reach out to this number within 24 hrs