Bone Marrow and Peripheral Blood Immune Responses Study

NCT05616546 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY0000385275N93021C00017
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza Vaccine; Bone Marrow; Immune Response

Outcome Measures

Primary Outcomes (6)

• 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.

  Study Days: 0, 7, 28, 90, 365

• 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.

  Study Days 0, 28, 365

• 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.

  Study Days: 0, 7, 28, 90, 365

• 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.

  Study Days 0, 28, 365

• 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.

  Study Days: 0, 7, 28, 90, 365

• 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.

  Study Days 0, 28, 365

Study Arms (1)

Influenza Vaccine

EXPERIMENTAL

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

Biological: Influenza Vaccine

Interventions

Influenza Vaccine BIOLOGICAL

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).

Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Edmund K Waller, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer C Truell, MA, MPH

CONTACT

404-778-0014; jennifer.carter.truell@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: November 15, 2022
• Study Start: October 16, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication, no end date
• 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

Locations

US (1)