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Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV) (LAIV)

Primary Purpose

Influenza, Human

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment Group Live Attenuated Flu Vaccine (LAIV)
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Influenza, Human focused on measuring Vaccine, Influenza, Efficacy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Missed getting the flu vaccine in the last year
  • No history of reactive airway disease
  • No history of allergy to LAIV
  • No history of allergy to IIV
  • Self-identify as healthy without an immunocompromising condition defined as cancer, autoimmune disease, organ transplant or receipt of steroids.

Exclusion Criteria:

  • History of reactive airway disease
  • History of allergy to LAIV or IIV
  • Do not self-identify as healthy

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2019
Last Updated
July 3, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04080245
Brief Title
Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
Acronym
LAIV
Official Title
Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
As yet the investigators do not understand if there are biomarkers of immune protection after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the hypothesis that the T-bet expressing fraction of flu-specific B cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. In this study the investigators will be providing the LAIV to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the LAIV also protects after the intramuscular influenza vaccination. Update: We have amended this protocol to study the antigen-specific B cell populations that circulate after LAIV or IIV prime and LAIV or IIV boost.
Detailed Description
Previously (1) the investigators established that a fluorochrome labeled reagent with the influenza antigen hemagglutinin accurately identified flu-specific B cells after inactivated influenza vaccination and we established that a subset of these flu-specfiic B cells that express the lineage defining master transcriptional regulator, T-bet, correlate with long lived antibody responses. As yet the investigators do not understand if there are biomarkers of immune protection after the Flumist or Live Attenuated Flu Vaccine (LAIV). Here the investigators test the hypothesis that the T-bet expressing fraction of flu-specific B cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. In this study the investigators will be providing the LAIV to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the LAIV also protects after the intramuscular influenza vaccination. Update: We have amended this protocol to study the antigen-specific B cell populations that circulate after LAIV or IIV prime and LAIV or IIV boost.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human
Keywords
Vaccine, Influenza, Efficacy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Treatment Group Live Attenuated Flu Vaccine (LAIV)
Intervention Description
We will administer LAIV once as a vaccine prime and IIV once as a vaccine boost with serial weekly blood draws for a month to validate a biomarker of LAIV efficacy.
Primary Outcome Measure Information:
Title
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Description
The investigators will perform a blood test on lymphocytes from circulating blood.
Time Frame
Baseline
Title
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Description
The investigators will perform a blood test on lymphocytes from circulating blood.
Time Frame
7 days post first injection
Title
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Description
The investigators will perform a blood test on lymphocytes from circulating blood.
Time Frame
14 days post first injection
Title
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Description
The investigators will perform a blood test on lymphocytes from circulating blood.
Time Frame
7 days post second injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Missed getting the flu vaccine in the last year No history of reactive airway disease No history of allergy to LAIV No history of allergy to IIV Self-identify as healthy without an immunocompromising condition defined as cancer, autoimmune disease, organ transplant or receipt of steroids. Exclusion Criteria: History of reactive airway disease History of allergy to LAIV or IIV Do not self-identify as healthy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anoma Nellore, MD
Phone
2059345191
Email
anellore@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anoma Nellore, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anoma Nellore, MD
First Name & Middle Initial & Last Name & Degree
Anoma Nellore, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)

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