Actively Recruiting
Characterizing the Human Airway Immune Response to FluMist Vaccination
Led by Washington University School of Medicine · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
164 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Characterizing the Human Airway Immune Response to FluMist Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18-40 years
- Able to understand and provide written informed consent
- In stable health based on medical history and physical exam related to history
You will not qualify if you...
- Prisoners
- Unable to provide full written informed consent
- Pregnant women, nursing mothers, or women planning pregnancy during study
- Female participants sexually active with male partners not using hormonal contraception or IUD
- Received seasonal influenza vaccine or had flu infection within past 9 months
- Received any vaccine within 28 days prior to pre-vaccination visit or planned non-study vaccine before day 28
- Current smokers
- Body mass index over 40
- Immunocompromised or received systemic immunosuppressants/immune-modifying drugs for over 14 days within 6 months prior
- Having symptomatic acute or unstable chronic disease needing medical or surgical care
- History of excessive alcohol use, drug abuse, psychiatric, social, or occupational conditions interfering with compliance
- Donated blood, blood products, or bone marrow within 30 days before study or planning to donate during or within 30 days after study
- Currently enrolled in another investigational agent trial unless only in follow-up and last dose was over 30 days or 5 half-lives ago
- Any condition deemed by investigator to interfere with trial conduct
- For bronchoscopy participants: chronic pulmonary, cardiovascular, neurologic, or hematologic disorders increasing sedation or procedure risk
- Coagulopathy contraindicating bronchoscopy (INR >1.4, PTT >40, platelet count <100,000)
- Significant pulmonary disease or low oxygen saturation on day of bronchoscopy
- Allergy or contraindication to anesthesia for bronchoscopy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Washington University in Saint Louis School of Medicine Emergency Care and Research Core
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
P
Philip A. Mudd, M.D., Ph.D.
CONTACT
J
Jamie Mills
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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