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Completed

NCT Number: NCT04164212

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

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)

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UAB Lung Health Center

Birmingham, Alabama, 35233, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flumist Quadrivalent Nasal Product

Drug

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

Other names: live attenuated influenza vaccine

Primary outcomes

  1. influenza virus replication

    Time frame: day 2

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

  2. markers of inflammation

    Time frame: change in inflammatory cytokines from baseline to day 2

    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

  3. cystic fibrosis transmembrane conductance regulator function

    Time frame: change in NPD from baseline to day 2

    nasal potential difference (NPD) measurement

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2019
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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