Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Influenza Clinical Trial

Official title:

Live Attenuated Influenza Vaccine as a Nasal Model for Influenza Infection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04164212
• Other study ID #: IRB-300004274
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Drug:
• Flumist Quadrivalent Nasal Product
FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer

Locations

Country	Name	City	State
United States	UAB Lung Health Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 2
Primary	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	change in inflammatory cytokines from baseline to day 2
Primary	cystic fibrosis transmembrane conductance regulator function	nasal potential difference (NPD) measurement	change in NPD from baseline to day 2