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NCT04080245 | RECRUITING | Influenza, Human


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

University of Alabama at Birmingham

Information provided by (Responsible Party):

Anoma in the

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.

Condition or disease

Influenza, Human

Intervention/treatment

Treatment Group Live Attenuated Flu Vaccine (LAIV)

Phase

EARLY_PHASE1

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
Estimated Enrollment : 18 participants
Masking : NONE
Primary Purpose : BASIC_SCIENCE
Official Title : Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
Actual Study Start Date : 2019-11-15
Estimated Primary Completion Date : 2025-06-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 50 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

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

Location Details

NCT04080245


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Locations


RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294

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