Clinical trial NCT04080245: Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
Official title: Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Influenza, Human
Keywords: Vaccine
Influenza
Efficacy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
timeFrame: Baseline
measure: Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
timeFrame: 7 days post first injection
measure: Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
timeFrame: 14 days post first injection
measure: Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
timeFrame: 7 days post second injection
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Anoma Nellore, MD
role: PRINCIPAL_INVESTIGATOR
References: