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Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection

Phase 4
Recruiting
Conditions
Influenza
Interventions
Drug: Flumist Quadrivalent Nasal Product
Registration Number
NCT04164212
Lead Sponsor
University of Alabama at Birmingham
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)

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
25
Inclusion Criteria
  • ages 18-49 years old,
  • not yet received influenza vaccine for 2019-2020, and
  • capable of giving signed informed consent.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
open labelFlumist Quadrivalent Nasal ProductFLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
Primary Outcome Measures
NameTimeMethod
markers of inflammationchange 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

influenza virus replicationday 2

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

cystic fibrosis transmembrane conductance regulator functionchange in NPD from baseline to day 2

nasal potential difference (NPD) measurement

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

UAB Lung Health Center

🇺🇸

Birmingham, Alabama, United States

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