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NCT04164212 | RECRUITING | Influenza

Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

David Lafon

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)

Condition or disease

Influenza

Intervention/treatment

Flumist Quadrivalent Nasal Product

Phase

PHASE4

Study Type : INTERVENTIONAL
Estimated Enrollment : 25 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection
Actual Study Start Date : 2020-09-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 49 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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.
Live Attenuated Influenza Vaccine As a Nasal Model for Influenza Infection

Location Details

NCT04164212

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

UAB Lung Health Center

Birmingham, Albama, United States, 35233