Characterizing the Human Airway Immune Response to FluMist Vaccination

NCT07177417 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-09-17

No results posted yet for this study

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

  • AstraZeneca

    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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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177417 on ClinicalTrials.gov