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Studying Immune Response to FluMist and Inactivated Flu Vaccines

This study aims to understand how your body's immune system responds to two common flu vaccines: FluMist (given as a nasal spray) and the inactivated influenza vaccine (given as a shot). Researchers want to see how these vaccines affect your immune response in your blood, nose, and lungs. You could join if you are a healthy adult between 18 and 40 years old and are not pregnant. The main goal is to measure changes in flu-specific antibodies in your lower lungs and nose between vaccination and 14 days later. All participants will receive one of the two seasonal flu vaccines, and blood and nose swab samples will be collected. The study status is currently unclear.

Study design
This is a randomized controlled trial involving 30 healthy participants. You would be randomly assigned to receive either the FluMist nasal spray or the inactivated influenza vaccine shot.
What's involved
Your participation would last for 4 months. You would have blood samples and nose swabs collected at several time points, and some participants will also have bronchoscopy procedures (a procedure to look inside your airways) before and after vaccination.
Compensation
Not stated in the trial record.
Follow-up
Blood and nasopharyngeal swabs will be collected up to 90 days after vaccination. For some participants, bronchoscopies will also be performed 90 days after vaccination.

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NCT07177417

Characterizing the Human Airway Immune Response to FluMist Vaccination

Recruiting
PHASE4Ages 18–40InterventionalBasic science
Washington University School of Medicine
~30 participants
Updated 2025-09-17 on ClinicalTrials.gov
What's tested:FluMistinactivated influenza vaccinebronchoscopy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in vaccine-specific mucosal antibody response following vaccination
Measured over From samples before vaccination and day 14 after vaccination.

Conditions

Healthy Young Adults
Influenza Vaccines
Influenza Vaccine Response

Explore related trials

Influenza

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

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

Who to contact

Philip A. Mudd, M.D., Ph.D.
[email protected]
314-273-1576
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.

What this trial measures

  • Change in vaccine-specific mucosal antibody response following vaccinationFrom samples before vaccination and day 14 after 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.