CompletedEarly Phase 1

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

United States10 participantsStarted 2019-11-15

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: Baseline

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: 7 days post first injection

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: 14 days post first injection

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: 7 days post second injection

Trial details

NCT IDNCT04080245

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-01

View on ClinicalTrials.gov More Influenza, Human trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: Baseline

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: 7 days post first injection

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: 14 days post first injection

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype

Timeframe: 7 days post second injection