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

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.

Study Overview

• Status: Recruiting
• Conditions: Influenza, Human
• Intervention / Treatment: Biological: Treatment Group Live Attenuated Flu Vaccine (LAIV)

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Anoma Nellore, MD; Phone Number: 2059345191; Email: anellore@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Anoma Nellore, MD
      • Principal Investigator: Anoma Nellore, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group	Biological: Treatment Group Live Attenuated Flu Vaccine (LAIV); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	7 days post first injection
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.	14 days post first injection
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.	7 days post second injection

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Anoma Nellore, MD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 3, 2019
• First Submitted That Met QC Criteria: September 5, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): July 6, 2023
• Last Update Submitted That Met QC Criteria: July 3, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Efficacy; Influenza; Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: IRB-300003669

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No