Characterizing the Human Airway Immune Response to FluMist Vaccination

NCT07177417 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 202505085
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

FluMist; bronchoscopy; bronchoalveolar lavage; endobronchial biopsy; nasopharyngeal swab; inactivated influenza vaccine

Outcome Measures

Primary Outcomes (1)

• Change in vaccine-specific mucosal antibody response following vaccination

  Measure the change in influenza vaccine strain-specific hemagglutinin and neuraminidase antibody titers found at the upper and lower airway mucosal surface between day 0 and day 14 after administration of FluMist intranasal influenza vaccination versus standard dose trivalent IIV using ELISA.

  From samples before vaccination and day 14 after vaccination.

Secondary Outcomes (5)

• Change in vaccine-specific circulating antibody following vaccination.

  From samples before vaccination and day 14 after vaccination.

• Change in influenza-specific mucosal and circulating CD8+ T cells following vaccination.

  From samples before vaccination and day 14 after vaccination.

• Change in influenza-specific mucosal and circulating B cells following vaccination.

  From samples before vaccination and day 14 after vaccination.

• Change in vaccine-specific mucosal antibody response 3 months after vaccination

  From samples taken on day 14 after vaccination and day 90 after vaccination.

• Change in influenza-specific mucosal and circulating CD8+ T cells and B cells 3 months after vaccination.

  From samples taken on day 14 after vaccination and day 90 after vaccination.

Study Arms (4)

FluMist bronchoscopy group

EXPERIMENTAL

Individuals who undergo all bronchoscopy procedures randomized to receive FluMist vaccine

Biological: FluMist; Procedure: bronchoscopy

FluMist no bronchoscopy group

EXPERIMENTAL

Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive FluMist vaccine

Biological: FluMist

inactivated influenza vaccine bronchoscopy group

ACTIVE COMPARATOR

Individuals who undergo all bronchoscopy procedures randomized to receive inactivated influenza vaccine

Biological: inactivated influenza vaccine; Procedure: bronchoscopy

inactivated influenza vaccine no bronchoscopy group

ACTIVE COMPARATOR

Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive inactivated influenza vaccine

Biological: inactivated influenza vaccine

Interventions

FluMist BIOLOGICAL

intranasal administered live attenuated influenza vaccine

FluMist bronchoscopy group; FluMist no bronchoscopy group

inactivated influenza vaccine BIOLOGICAL

intramuscular administered inactivated influenza vaccine

Also known as: FLUARIX

inactivated influenza vaccine bronchoscopy group; inactivated influenza vaccine no bronchoscopy group

bronchoscopy PROCEDURE

bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling

FluMist bronchoscopy group; inactivated influenza vaccine bronchoscopy group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18-40 years
• Able to understand and give written informed consent
• In stable health, as determined by medical history and targeted physical exam related to the history

You may not qualify if:

• Prisoners
• Anyone unable to provide full written informed consent
• Pregnant women and nursing mothers or women who are planning to become pregnant during the study interval
• Female subjects who are sexually active with male partners who are not actively on hormonal contraception or who do not have an IUD in place
• Vaccination with a seasonal influenza vaccine or documented infection with seasonal influenza in the past 9 months
• Receipt of any vaccine in the 28 days prior to the pre-vaccination study visit or planned receipt of any non-study vaccine before completion of study day 28 visit
• Current smokers
• BMI \> 40
• Individuals with an immunocompromising medical condition or who have received systemic immunosuppressants or immune-modifying drugs for \> 14 days in total within 6 months prior to screening (for corticosteroids ≥ 10 mg/day of prednisone equivalent for \> 14 days total) or is anticipating the need for immunosuppressive treatment at any time during participation in the study
• Individuals who currently have symptomatic acute or unstable chronic disease requiring medical or surgical care, to include significant change in therapy or hospitalization, at the discretion of the investigator
• History of excessive alcohol consumption, drug abuse, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the study
• Have donated blood, blood products, or bone marrow within 30 days before study entry, plan to donate blood at any time during the duration of study participation, or plan to donate blood within 30 days after the last blood draw.
• Current ongoing participation in a clinical trial evaluating an investigational agent unless the trial is in follow up only and the last dose of the investigational agent was taken \>30 days or \>5 half-lives prior to enrollment, whichever is greater.
• Any condition in the opinion of the investigator that would interfere with the proper conduct of the trial.
• For participants willing to undergo bronchoscopy:

Sponsors & Collaborators

• Washington University School of Medicine: lead
• AstraZeneca: collaborator

Study Sites (1)

Washington University in Saint Louis School of Medicine Emergency Care and Research Core

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

FluMist; fluarix; Bronchoscopy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Philip A. Mudd, M.D., Ph.D.

  Washington University in Saint Louis School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip A. Mudd, M.D., Ph.D.

CONTACT

314-273-1576; pmudd@wustl.edu

Jamie Mills

CONTACT

314-305-1054; jamiem@wustl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)