Bone Marrow and Peripheral Blood Immune Responses to Influenza Vaccine

This study is looking at how your body's immune system responds to the seasonal flu vaccine (a licensed, FDA-approved inactivated influenza vaccine). Researchers want to understand how your immune system, specifically certain immune cells called B-cells, react to the vaccine in both your blood and bone marrow. They will track these responses over time to see how long the protection lasts. This study is for healthy adults aged 18 to 64. The goal is to learn more about how the flu vaccine works to protect you from serious illness, as the flu can be very dangerous. The study is considered successful if it helps us better understand the immune response to the flu vaccine.

Study design
This is an open-label, single-arm observational study involving 90 participants. It means everyone receives the same treatment, and both you and the study team will know what vaccine you are getting.
What's involved
You will receive one dose of the seasonal flu vaccine. You will also provide several blood samples and bone marrow samples over a period of up to one year.
Compensation
Not stated in the trial record.
Follow-up
Your immune response will be measured for up to one year after vaccination.

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NCT05616546

Bone Marrow and Peripheral Blood Immune Responses Study

Recruiting
PHASE4Ages 18–64InterventionalBasic science
Emory University
~90 participants
Updated 2024-01-31 on ClinicalTrials.gov
What's tested:Influenza Vaccine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in clonal diversity of B-Cell response to Influenza in blood
Measured over Study Days: 0, 7, 28, 90, 365
+5 more outcomes measured
Influenza
1 sites across 1 states
Georgia1
  • Edmund K Waller, MD, PhD · PRINCIPAL_INVESTIGATOR · Emory University

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Eligibility criteria

Inclusion

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

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.
  • Changes in clonal diversity of B-Cell response to Influenza in bloodStudy Days: 0, 7, 28, 90, 365

    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 marrowStudy Days 0, 28, 365

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

    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 marrowStudy Days 0, 28, 365

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

    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 InfluenzaStudy Days 0, 28, 365

    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.