Influenza
Conditions
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)
Interventions
DRUGFlumist Quadrivalent Nasal Product
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
Sponsors
University of Alabama at Birmingham
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| influenza virus replication | 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 |
| markers of inflammation | 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 |
| cystic fibrosis transmembrane conductance regulator function | change in NPD from baseline to day 2 | nasal potential difference (NPD) measurement |
Countries
United States
Outcome results
None listed