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COMPLETEDPHASE4

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

NCT04164212•University of Alabama at Birmingham

Summary

The purpose of this study is to develop a nasal model for influenza infection using the live attenuated influenza vaccine (LAIV). The investigators will administer LAIV to healthy adult volunteers in order to simulate influenza infection, and obtain nasal specimens to measure influenza virus and inflammatory/immune responses. In a subset of participants, cystic fibrosis transmembrane conductance regulator (CFTR) function will also be evaluated via measurement of nasal potential difference (NPD)

Eligibility

Age

18 - 49 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•ages 18-49 years old,
•not yet received influenza vaccine for 2019-2020, and
•capable of giving signed informed consent.

Exclusion Criteria

•Immunocompromising condition (e.g. HIV/AIDS, chemotherapy, immune suppressing medications),
•active smoking within past 6 months,
•asthma, chronic lung/liver/kidney /neurologic/hematologic/metabolic disorders,cardiovascular disease (excluding isolated hypertension), diabetes mellitus, disease, congestive heart failure,
•pregnancy,
•current or recent (within the past month) upper/lower respiratory tract infection, chronic sinusitis/nasal allergies requiring frequent or daily therapy (including topical corticosteroids),
•prior adverse reaction to influenza vaccine,
•history of Guillain-Barre syndrome,
•egg allergy,
•close contact with an individual with severe immunodeficiency/immunosuppression.

Locations (1)

UAB Lung Health Center

Birmingham, Alabama, United States

Key Dates

Start Date

September 1, 2020

Primary Completion Date

January 22, 2026

Completion Date

January 22, 2026

Last Updated

February 20, 2026

Enrollment

ACTUAL participants

Conditions

Influenza

Interventions

Flumist Quadrivalent Nasal Product

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Inclusion Criteria

Exclusion Criteria

Phase 1/2 Study of a Plant-Based Seasonal Recombinant Trivalent VLP Influenza Vaccine

A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts

Dime La VerDAD: Verify, Debunk, and Disseminate

Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)

Effectiveness and Implementation of a National Guideline for Acute Respiratory Tract Infections to Reduce Antibiotic Prescribing in Swiss Primary Care

Administration of the Nasal Influenza Vaccine to Children in Daycare or at a Healthcare Facility