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

Influenza, Human Clinical Trial

— LAIV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04080245
• Other study ID #: IRB-300003669
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 15, 2019
• Est. completion date: December 1, 2025

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: Anoma Nellore, MD
• Phone: 2059345191
• Email: anellore[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza, Human

Intervention

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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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