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Purpose

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)

Condition

Eligibility

Eligible Ages
Between 18 Years and 49 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
open label 		FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
  • Drug: Flumist Quadrivalent Nasal Product
    FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
    Other names:
    • live attenuated influenza vaccine

Recruiting Locations

UAB Lung Health Center
Birmingham, Alabama 35233
Contact:
David LaFon, MD
2059345555
dlafon@uabmc.edu

More Details

Status
Recruiting
Sponsor
University of Alabama at Birmingham

Study Contact

David LaFon, MD
205-934-0266
dlafon@uabmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.