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Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Primary Purpose

Influenza

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Flumist Quadrivalent Nasal Product
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Influenza

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • UAB Lung Health Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

open label

Arm Description

FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer

Outcomes

Primary Outcome Measures

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
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
cystic fibrosis transmembrane conductance regulator function
nasal potential difference (NPD) measurement

Secondary Outcome Measures

Full Information

First Posted
November 7, 2019
Last Updated
July 6, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04164212
Brief Title
Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
Official Title
Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
open label
Arm Type
Other
Arm Description
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
Intervention Type
Drug
Intervention Name(s)
Flumist Quadrivalent Nasal Product
Other Intervention Name(s)
live attenuated influenza vaccine
Intervention Description
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
Primary Outcome Measure Information:
Title
influenza virus replication
Description
virus replication will be measured using RT-PCR and reported as genomic units, from samples obtained from nasal washing and nasal oropharyngeal swabs
Time Frame
day 2
Title
markers of inflammation
Description
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
Time Frame
change in inflammatory cytokines from baseline to day 2
Title
cystic fibrosis transmembrane conductance regulator function
Description
nasal potential difference (NPD) measurement
Time Frame
change in NPD from baseline to day 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
UAB Lung Health Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

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