EVax-3: Human Upper and Lower Airway Mucosal Immune Response to FluMist Vaccination
Washington University School of Medicine
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.
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 samp…
Eligibility
- Age range
- 18–40 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 Criteria: * 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 vacci…
Interventions
- BiologicalFluMist
intranasal administered live attenuated influenza vaccine
- Biologicalinactivated influenza vaccine
intramuscular administered inactivated influenza vaccine
- Procedurebronchoscopy
bronchoscopy with bronchoalveolar lavage and endobronchial biopsy sampling
Location
- Washington University in Saint Louis School of Medicine Emergency Care and Research CoreSt Louis, Missouri