Influenza, HumanEarly Phase 1LAIVNCT04080245

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

A Early Phase 1 study testing Treatment Group Live Attenuated Flu Vaccine (LAIV) in people with Influenza, Human, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Human
What is being tested?: Treatment Group Live Attenuated Flu Vaccine (LAIV)
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2019to 1 Jun 2025
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

History of reactive airway disease
History of allergy to LAIV or IIV
Do not self-identify as healthy

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Alabama at Birmingham
Birmingham, Alabama, 35294

Other trials in United States

About this study

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.

Read the 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.

Conditions: Influenza, Human
Being tested: Treatment Group Live Attenuated Flu Vaccine (LAIV)
Keywords: Vaccine, Influenza, Efficacy
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment Group Live Attenuated Flu Vaccine (LAIV)Biological
We will administer LAIV once as a vaccine prime and IIV once as a vaccine boost with serial weekly blood draws for a month to validate a biomarker of LAIV efficacy.

Study groups in NCT04080245
Study group	Role	What they receive
Treatment Group	Experimental	Not described Receives: Biological: Treatment Group Live Attenuated Flu Vaccine (LAIV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Measured: Baseline
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Measured: 7 days post first injection
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Measured: 14 days post first injection
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
The investigators will perform a blood test on lymphocytes from circulating blood.
Measured: 7 days post second injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 20191 Jun 2025

First posted6 Sep 2019
Study start15 Nov 2019
Primary completion1 Jun 2025
Study completion1 Jun 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Influenza, HumanStudies of the same condition, open and under way.
More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04080245
Sponsor's protocol ID: IRB-300003669
Acronym: LAIV
Status last verified: Jun 2025
First submitted: 3 Sep 2019
Last updated: 11 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Influenza, Human trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)
ClinicalTrials.gov ID: NCT04080245
Acronym / sponsor ID: LAIV / IRB-300003669
Conditions: Influenza, Human
Keywords: Vaccine, Influenza, Efficacy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: University of Alabama at BirminghamUniversity, hospital or other
Study start: 15 Nov 2019 (actual)
Primary completion: 1 Jun 2025 (actual)
Study completion: 1 Jun 2025 (actual)
First posted: 6 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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 design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Group	Experimental	Biological: Treatment Group Live Attenuated Flu Vaccine (LAIV)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (3 listed)

History of reactive airway disease
History of allergy to LAIV or IIV
Do not self-identify as healthy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treatment Group Live Attenuated Flu Vaccine (LAIV)We will administer LAIV once as a vaccine prime and IIV once as a vaccine boost with serial weekly blood draws for a month to validate a biomarker of LAIV efficacy.	Biological	Treatment Group

Primary outcome

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Time frame: Baseline
The investigators will perform a blood test on lymphocytes from circulating blood.
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Time frame: 7 days post first injection
The investigators will perform a blood test on lymphocytes from circulating blood.
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Time frame: 14 days post first injection
The investigators will perform a blood test on lymphocytes from circulating blood.
Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype
Time frame: 7 days post second injection
The investigators will perform a blood test on lymphocytes from circulating blood.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
Individual participant dataSharing planned: No

Related trials for Influenza, Human

Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
Not yet recruitingPhase 1
Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS
ARDS, Covid19
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
RecruitingPhase 4
Impact of Egg-Based and Cell-Based Vaccine Platforms on Immune Responses to Repeated Influenza Vaccination
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RecruitingEarly Phase 1
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Vaccine Reaction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anoma Nellore, MD principal investigator

University of Alabama at Birmingham

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Treatment Group Live Attenuated Flu Vaccine (LAIV) in people with Influenza, Human, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outcome Measure: Participants with a positive T-bet expressing Flu-specific B cell subtype (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080245.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.