Clinical trial NCT05616546: 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
Overall status: RECRUITING
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza Vaccine
Bone Marrow
Immune Response
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2022-11-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Changes in clonal diversity of B-Cell response to Influenza in blood
timeFrame: Study Days: 0, 7, 28, 90, 365
measure: Changes in clonal diversity of B-Cell response to Influenza in bone marrow
timeFrame: Study Days 0, 28, 365
measure: Changes in magnitude of B-Cell response to Influenza in blood
timeFrame: Study Days: 0, 7, 28, 90, 365
measure: Changes in magnitude of B-Cell response to Influenza in bone marrow
timeFrame: Study Days 0, 28, 365
measure: Changes in persistence of B-Cell response to Influenza in blood
timeFrame: Study Days: 0, 7, 28, 90, 365
measure: Changes in Bone marrow persistence of B-Cell response to Influenza
timeFrame: Study Days 0, 28, 365
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Edmund K Waller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: