NCT04164212

Brief 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2020

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2026

Completed
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

5.4 years

First QC Date

November 7, 2019

Last Update Submit

February 18, 2026

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

  • influenza virus replication

    virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs

    day 2

  • markers of inflammation

    a standard panel of inflammatory cytokines (Luminex Performance Human XL Cytokine Discovery Panel assay, R\&D Systems; results reported in pg/ml) will be measured in samples obtained from nasal washing and nasal oropharyngeal swabs

    change in inflammatory cytokines from baseline to day 2

  • cystic fibrosis transmembrane conductance regulator function

    nasal potential difference (NPD) measurement

    change in NPD from baseline to day 2

Study Arms (1)

open label

OTHER

FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer

Drug: Flumist Quadrivalent Nasal Product

Interventions

Flumist Quadrivalent Nasal ProductDRUG

FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer

Also known as: live attenuated influenza vaccine
open label

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAB Lung Health Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (1)

  • Earnhardt EY, Tipper JL, Hanafy MA, Lazrak A, Lopez A, Perritt SE, LaFon DC, Mobley JA, Solomon GM, Harrod KS. Endoplasmic Reticulum Stress Disrupts the Airway Epithelium and Reduces Host Defense during Influenza A Virus Infection. Am J Respir Cell Mol Biol. 2026 Jan 1;74(1):40-51. doi: 10.1165/rcmb.2025-0141OC.

    PMID: 40720746DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 7, 2019

First Posted

November 15, 2019

Study Start

September 1, 2020

Primary Completion

January 22, 2026

Study Completion

January 22, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Locations

US(1)