drugset / Trial / NCT04080245

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

NCT04080245 ↗

Phase 0 Completed 10 enrolled University of Alabama at Birmingham
NaSingle-groupOpen-labelBasic science

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.

Timeline

Start
2019-11-15
Primary completion
2025-06-01
Completion
2025-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject IIV Vaccine — Intramuscular
Subject Live Attenuated Flu Vaccine Vaccine — —

Indications