Characterizing the Human Airway Immune Response to FluMist Vaccination
NCT07177417 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2025-09-17
Summary
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.
Conditions
- Healthy Young Adults
- Influenza Vaccines
- Influenza Vaccine Response
Interventions
- BIOLOGICAL
-
FluMist
intranasal administered live attenuated influenza vaccine
- BIOLOGICAL
-
inactivated influenza vaccine
intramuscular administered inactivated influenza vaccine
- PROCEDURE
-
bronchoscopy
bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling
Sponsors & Collaborators
- collaborator INDUSTRY
-
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Philip A. Mudd, M.D., Ph.D. · Washington University in Saint Louis School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-09-09
- Primary Completion
- 2026-09-30
- Completion
- 2028-11-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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