Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Study Overview
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Brief Summary
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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)

Official Title
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Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Conditions
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Influenza

Intervention / Treatment
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* Drug: Flumist Quadrivalent Nasal Product


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: open label<br>FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer | Drug: Flumist Quadrivalent Nasal Product<br>* FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer<br>* Other names: live attenuated influenza vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |