Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection
- 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
- ages 18-49 years old,
- not yet received influenza vaccine for 2019-2020, and
- capable of giving signed informed consent.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description open label Flumist Quadrivalent Nasal Product FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
- Primary Outcome Measures
Name Time Method 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
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
cystic fibrosis transmembrane conductance regulator function change in NPD from baseline to day 2 nasal potential difference (NPD) measurement
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UAB Lung Health Center
🇺🇸Birmingham, Alabama, United States