RECRUITING

Characterizing the Human Airway Immune Response to FluMist Vaccination

Conditions

Healthy Young Adults Influenza Vaccines Influenza Vaccine Response FluMist bronchoscopy bronchoalveolar lavage endobronchial biopsy nasopharyngeal swab inactivated influenza vaccine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

EVax-3: Human Upper and Lower Airway Mucosal Immune Response to FluMist Vaccination

Quick Facts

Study Start:2025-09-09

Study Completion:2028-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07177417

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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. * Any known chronic pulmonary, cardiovascular, neurologic or hematologic disorder that could, in the opinion of the physician bronchoscopist or the principal investigator, put the subject at unnecessary risk from the sedation and bronchoscopy procedures. These conditions may include, but are not limited to, the following: asthma, COPD, obstructive sleep apnea, pulmonary fibrosis, cystic fibrosis, pulmonary hypertension, heart failure, previous myocardial infarction, hypertrophic cardiomyopathy, supraventricular tachycardia, paraplegia, quadriplegia, epilepsy, sickle cell disease, hemophilia, chronic anemia or active cancer. * Coagulopathy (primary or iatrogenic) which would contraindicate bronchoscopy for participants willing to have those procedures done. Any participant with an INR\>1.4, PTT\>40 or platelet count \<100,000 at study screening will not be eligible for bronchoscopy. * Evidence of significant pulmonary disease on the day of bronchoscopy, including pulse oximetry with oxygen saturation of 92% or less on room air, or infiltrate or pleural effusion on an upright PA and lateral chest x-ray performed on the day of bronchoscopy. * Allergy or contraindication to anesthesia for participants willing to have bronchoscopy done.

Inclusion Criteria

Exclusion Criteria

* 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

* 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.
* Any known chronic pulmonary, cardiovascular, neurologic or hematologic disorder that could, in the opinion of the physician bronchoscopist or the principal investigator, put the subject at unnecessary risk from the sedation and bronchoscopy procedures. These conditions may include, but are not limited to, the following: asthma, COPD, obstructive sleep apnea, pulmonary fibrosis, cystic fibrosis, pulmonary hypertension, heart failure, previous myocardial infarction, hypertrophic cardiomyopathy, supraventricular tachycardia, paraplegia, quadriplegia, epilepsy, sickle cell disease, hemophilia, chronic anemia or active cancer.
* Coagulopathy (primary or iatrogenic) which would contraindicate bronchoscopy for participants willing to have those procedures done. Any participant with an INR\>1.4, PTT\>40 or platelet count \<100,000 at study screening will not be eligible for bronchoscopy.
* Evidence of significant pulmonary disease on the day of bronchoscopy, including pulse oximetry with oxygen saturation of 92% or less on room air, or infiltrate or pleural effusion on an upright PA and lateral chest x-ray performed on the day of bronchoscopy.
* Allergy or contraindication to anesthesia for participants willing to have bronchoscopy done.

Contacts and Locations

Study Contact

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

CONTACT

314-273-1576

pmudd@wustl.edu

Jamie Mills

CONTACT

314-305-1054

jamiem@wustl.edu

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

Washington University in Saint Louis School of Medicine

Study Locations (Sites)

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

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Philip A. Mudd, M.D., Ph.D., PRINCIPAL_INVESTIGATOR, Washington University in Saint Louis School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-09

Study Completion Date2028-11

Study Record Updates

Study Start Date2025-09-09

Study Completion Date2028-11

Terms related to this study

Keywords Provided by Researchers

FluMist
bronchoscopy
bronchoalveolar lavage
endobronchial biopsy
nasopharyngeal swab
inactivated influenza vaccine

Additional Relevant MeSH Terms

Healthy Young Adults
Influenza Vaccines
Influenza Vaccine Response