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Healthy Young AdultsPhase 4EVax-3NCT07177417

Characterizing the Human Airway Immune Response to FluMist Vaccination

A Phase 4 study testing FluMist, inactivated influenza vaccine and bronchoscopy in people with Healthy Young Adults and Influenza Vaccines, run by Washington University School of Medicine at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
What is being tested?
FluMist, inactivated influenza vaccine and bronchoscopy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
9 Sep 2025to Nov 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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:
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

314-273-1576

pmudd@wustl.edu

Jamie Mills contact

314-305-1054

jamiem@wustl.edu

United States1 site, 1 recruiting

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

    St Louis, Missouri, 63110

    Jamie Mills, 314-305-1054, jamiem@wustl.edu

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

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Study Design/Methodology: Prospective randomized controlled trial; Study Duration: 2 years; Number of Subjects: 30; Subject Participation Duration: 4 months; Description of Interventions: Eligible healthy participants who have not received a seasonal influenza vaccine within the past 9 months will complete written informed consent. Enrolled participants will be randomized to receive either an FDA-approved intramuscular seasonal egg-based inactivated influenza vaccine (IIV) (N=15) or the FDA-approved seasonal FluMist intranasal live attenuated influenza vaccine (N=15) on study day 0. Blood samples and nasopharyngeal swabs will be collected at the time of study enrollment (up to 45 days prior to vaccination) and on days 3±1, 7±2, 14±3, 28±5, and 90±14 post-vaccination. Sixteen participants (N=8 in each vaccine group) will be enrolled for optional research bronchoscopy procedures. Research bronchoscopies will include bronchoalveolar lavage (BAL) and endobronchial biopsy (EBBx) sample collection. Research bronchoscopies will be performed prior to vaccination and on study days 14±3 and 90±14. Screening safety laboratory studies and screening chest x-ray imaging will be performed on subjects undergoing research bronchoscopies.

Being tested
FluMist, inactivated influenza vaccine, bronchoscopy
Keywords
FluMist, bronchoscopy, bronchoalveolar lavage, endobronchial biopsy, nasopharyngeal swab, inactivated influenza vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FluMistBiological

    intranasal administered live attenuated influenza vaccine

  • inactivated influenza vaccineBiological

    Also called FLUARIX

    intramuscular administered inactivated influenza vaccine

  • bronchoscopyProcedure or surgery

    bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling

Study groups in NCT07177417
Study groupRoleWhat they receive
FluMist bronchoscopy groupExperimentalIndividuals who undergo all bronchoscopy procedures randomized to receive FluMist vaccine
Receives: Biological: FluMist; Procedure: bronchoscopy
FluMist no bronchoscopy groupExperimentalIndividuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive FluMist vaccine
Receives: Biological: FluMist
inactivated influenza vaccine bronchoscopy groupActive comparatorIndividuals who undergo all bronchoscopy procedures randomized to receive inactivated influenza vaccine
Receives: Biological: inactivated influenza vaccine; Procedure: bronchoscopy
inactivated influenza vaccine no bronchoscopy groupActive comparatorIndividuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive inactivated influenza vaccine
Receives: Biological: inactivated influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From samples before vaccination and day 14 after vaccination.

Secondary outcomes (5)

  1. Change in vaccine-specific circulating antibody following vaccination.

    Measure the change in influenza vaccine strain-specific antibody titers found in blood between day 0 and day 14 after administration of FluMist intranasal influenza vaccination versus standard dose IIV using ELISA.

    Measured: From samples before vaccination and day 14 after vaccination.

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

    Measure the change in the magnitude of influenza-specific CD8+ T cells found in the blood, the nasopharynx, the lower airways and the lung tissue between day 0 and day 14 using flow cytometry with influenza-specific HLA class I tetramer reagents.

    Measured: From samples before vaccination and day 14 after vaccination.

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

    Measure the change in the magnitude of influenza-specific B cells found in the blood and the lung tissue between day 0 and day 14 using flow cytometry with influenza strain-specific fluorescently-labeled HA probes.

    Measured: From samples before vaccination and day 14 after vaccination.

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

    Measure the change in influenza vaccine strain-specific antibody titers found at the lower airway mucosal surface and at the nasopharyngeal mucosal surface between day 14 and day 90 using ELISA.

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

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

    Measure the change in the magnitude of influenza-specific CD8+ T cells and B cells found in the blood, the nasopharynx, the lower airways and the lung tissue between day 14 and day 90 using flow cytometry with influenza-specific HLA class I tetramer reagents and strain-specific fluorescently-labeled HA probes.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start9 Sep 2025
  3. Primary completionSep 2026 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07177417
Sponsor's protocol ID
202505085
Acronym
EVax-3
Status last verified
Sep 2025
First submitted
9 Sep 2025
Last updated
17 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FluMist, inactivated influenza vaccine and bronchoscopy in people with Healthy Young Adults and Influenza Vaccines, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Philip A. Mudd, M.D., Ph.D. (314-273-1576, pmudd@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vaccine-specific mucosal antibody response following vaccination (time frame: From samples before vaccination and day 14 after vaccination.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07177417.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.

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