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

NCT04080245 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB-300003669
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza, Human

Keywords

Vaccine; Influenza; Efficacy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Treatment Group

EXPERIMENTAL

Biological: Treatment Group Live Attenuated Flu Vaccine (LAIV)

Interventions

Treatment Group Live Attenuated Flu Vaccine (LAIV) BIOLOGICAL

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• Anoma Nellore, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: November 15, 2019
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)