Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

NCT ID: NCT04164212

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2026-02-28

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)

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open label

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

Group Type OTHER

Flumist Quadrivalent Nasal Product

Intervention Type DRUG

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

Interventions

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Flumist Quadrivalent Nasal Product

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

Intervention Type DRUG

Other Intervention Names

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live attenuated influenza vaccine

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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David Lafon

Clinical Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UAB Lung Health Center

Birmingham, Alabama, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David LaFon, MD

Role: CONTACT

Phone: 205-934-0266

Email: [email protected]

Facility Contacts

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David LaFon, MD

Role: primary

Other Identifiers

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R01HL149944

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300004274

Identifier Type: -

Identifier Source: org_study_id