Actively Recruiting
EVax-3: Human Upper and Lower Airway Mucosal Immune Response to FluMist Vaccination
Led by Washington University School of Medicine · Updated on 2025-09-17
30
Participants Needed
1
Research Sites
113 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
Researchers are studying the immune response in the blood, nose, and lungs after vaccination with either the FDA-approved inactivated influenza vaccine or the FDA-approved intranasal FluMist vaccine. The study focuses on healthy adults aged 18 to 40 who have not received a seasonal flu vaccine in the past nine months. The main goal is to measure changes in influenza vaccine-specific antibodies in the lower lungs and nose within 14 days after vaccination. Participants will be randomly assigned to receive either the intramuscular inactivated influenza vaccine or the intranasal FluMist vaccine on the first day of the study. Blood samples and nasopharyngeal swabs will be collected before vaccination and at several points up to 90 days after vaccination. A subgroup of 16 participants will undergo optional bronchoscopy procedures, including bronchoalveolar lavage and endobronchial biopsy, before vaccination and at days 14 and 90 to study immune responses in the lower lungs. During the study, participants will have multiple visits for sample collection and assessments over about four months. Those undergoing bronchoscopy will have additional safety lab tests and chest X-rays. Researchers will analyze antibody and immune cell changes in blood and mucosal samples to evaluate vaccine responses. The study also monitors safety and immune changes up to three months after vaccination.
CONDITIONS
Brief Title
Characterizing the Human Airway Immune Response to FluMist Vaccination
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults aged 18 to 40 years
- Able to understand and provide written informed consent
- In stable health based on medical history and physical exam related to health history
You will not qualify if you...
- Prisoners
- Unable to provide full written informed consent
- Pregnant or nursing women, or planning pregnancy during the study
- Female subjects sexually active with male partners not using hormonal contraception or IUD
- Vaccinated for seasonal influenza or had flu infection in past 9 months
- Received any vaccine within 28 days before study or planned before day 28 visit
- Current smokers
- Body mass index greater than 40
- Immunocompromised individuals or recent systemic immunosuppressant use
- Symptomatic acute or unstable chronic disease needing medical or surgical care
- History of excessive alcohol, drug abuse, psychiatric, social, or occupational conditions affecting compliance
- Recent blood or bone marrow donation within 30 days before or planned during study
- Ongoing participation in investigational agent trials unless in follow-up only with last dose over 30 days ago
- Any condition interfering with proper conduct of the trial
- For bronchoscopy: chronic pulmonary, cardiovascular, neurologic, or hematologic disorders posing risk
- Coagulopathy contraindicating bronchoscopy
- Significant pulmonary disease on day of bronchoscopy
- Allergy or contraindication to anesthesia for bronchoscopy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening safety laboratory studies and chest x-ray imaging for participants undergoing bronchoscopy
Duration - Single day (study day 0)
Participants are randomized to receive either the FluMist intranasal vaccine or the inactivated influenza vaccine by injection on study day 0.
1 vaccination visit (in-person)
Duration - Approximately 3 months post-vaccination
Participants provide blood samples and nasopharyngeal swabs at multiple time points to monitor immune response to the vaccine.
Visits on days 3±1, 7±2, 14±3, 28±5, and 90±14 post-vaccination
Duration - Approximately 3 months post-vaccination
A subset of participants undergo bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling before vaccination and on days 14±3 and 90±14 post-vaccination.
Up to 3 bronchoscopy visits (before vaccination, day 14±3, day 90±14)
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.
J
Jamie Mills
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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