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NCT04080245 · ClinicalTrials.gov registry record · Early Phase 1
Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
A Early Phase 1 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT04080245: Completed Early Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT04080245 is a Early Phase 1 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04080245, a Early Phase 1 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
The investigators will perform a blood test on lymphocytes from circulating blood.
Interventions
- BIOLOGICAL Treatment Group Live Attenuated Flu Vaccine (LAIV)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2025-06-01 |
| Phase | Early Phase 1 |
What the finished NCT04080245 record still lists
NCT04080245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Treatment Group Live Attenuated Flu Vaccine (LAIV) is the first listed.
NCT04080245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04080245 about?
NCT04080245 is a clinical study titled "Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)". 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 serv...
What is the current status of trial NCT04080245?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2019-11-15. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT04080245?
The interventions under investigation include: Treatment Group Live Attenuated Flu Vaccine (LAIV) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04080245?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04080245's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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