Characterizing the Human Airway Immune Response to FluMist Vaccination

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT07177417
Phase
PHASE4
Status
Recruiting
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Conditions

  • Healthy Young Adults
  • Influenza Vaccine Response
  • Influenza Vaccines

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • FluMist — BIOLOGICAL
    intranasal administered live attenuated influenza vaccine
  • inactivated influenza vaccine — BIOLOGICAL
    intramuscular administered inactivated influenza vaccine
  • bronchoscopy — PROCEDURE
    bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling

Study Details

The goal of this clinical trial is to measure the immune response in the blood, nose, and lungs after participants receive either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study will evaluate immune responses in groups of healthy, non-pregnant, volunteers between the ages of 18 and 40. The main purpose of the study is to measure the change in influenza vaccine-specific antibodies in the lower lungs and nose between vaccination and 14 days after participants receive the vaccine. All participants will be randomized to receive one of the two seasonal flu vaccines and will have blood and back of the nose swabs collected throughout the study. Some study participants will choose to undergo optional bronchoscopy procedures and will be included in the part of the study looking at lower lung immune responses.

Key Dates

Start date
Sep 9, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: FluMist bronchoscopy group
    Individuals who undergo all bronchoscopy procedures randomized to receive FluMist vaccine
  • Experimental: FluMist no bronchoscopy group
    Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive FluMist vaccine
  • Active Comparator: inactivated influenza vaccine bronchoscopy group
    Individuals who undergo all bronchoscopy procedures randomized to receive inactivated influenza vaccine
  • Active Comparator: inactivated influenza vaccine no bronchoscopy group
    Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive inactivated influenza vaccine

Primary Outcome Measure

Change in vaccine-specific mucosal antibody response following vaccination [ Time Frame: From samples before vaccination and day 14 after vaccination. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University in Saint Louis School of Medicine Emergency Care and Research CoreSt LouisMissouri63110
Jamie Mills
[email protected]
314-305-1054
Philip A. Mudd, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Washington University in Saint Louis School of Medicine Emergency Care and Research Core· St Louis, MO

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