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Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04164212
Recruitment Status : Not yet recruiting
First Posted : November 15, 2019
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
David Lafon, 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.

Condition or disease Intervention/treatment Phase
Influenza Drug: Flumist Quadrivalent Nasal Product Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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 Name: live attenuated influenza vaccine




Primary Outcome Measures :
  1. influenza virus replication [ Time Frame: 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

  2. markers of inflammation [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164212


Contacts
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Contact: David LaFon, MD 2-5-934-0266 dlafon@uabmc.edu

Sponsors and Collaborators
University of Alabama at Birmingham

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Responsible Party: David Lafon, Clinical Instructor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT04164212    
Other Study ID Numbers: IRB-300004274
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020

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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
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs