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

Early Phase 1

Recruiting

• Conditions: Influenza, Human
• Interventions: Biological: Treatment Group Live Attenuated Flu Vaccine (LAIV)

• Registration Number: NCT04080245
• Lead Sponsor: University of Alabama at Birmingham

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.

Study Timeline

• Study First Submitted: 2019-09-03
• Study First Submitted QC: 2019-09-05
• Study First Posted: 2019-09-06
• Study Start: 2019-11-15
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2025-06-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	Treatment Group Live Attenuated Flu Vaccine (LAIV)	-

Primary Outcome Measures

Name	Time	Method
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype	7 days post second injection	The investigators will perform a blood test on lymphocytes from circulating blood.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States