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

Status: Recruiting
Location: See location...
Intervention Type: Biological, Procedure
Study Type: Interventional
Study Phase: Phase 4
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• 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

Locations
United States
Missouri
Washington University in Saint Louis School of Medicine Emergency Care and Research Core
RECRUITING
St Louis
Contact Information
Primary
Philip A. Mudd, M.D., Ph.D.
pmudd@wustl.edu
314-273-1576
Backup
Jamie Mills
jamiem@wustl.edu
314-305-1054
Time Frame
Start Date: 2025-09-09
Estimated Completion Date: 2028-11
Participants
Target number of participants: 30
Treatments
Experimental: FluMist bronchoscopy group
Individuals who undergo all bronchoscopy procedures randomized to receive FluMist vaccine
Experimental: FluMist no bronchoscopy group
Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive FluMist vaccine
Active_comparator: inactivated influenza vaccine bronchoscopy group
Individuals who undergo all bronchoscopy procedures randomized to receive inactivated influenza vaccine
Active_comparator: inactivated influenza vaccine no bronchoscopy group
Individuals who do not complete day 14 or day 90 bronchoscopy procedures randomized to receive inactivated influenza vaccine
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: AstraZeneca

This content was sourced from clinicaltrials.gov