Intranasal LAIV Mucosal Immunity Examination
Part of paid clinical trials in Baltimore, Maryland.
- Sponsor
- University of Maryland, Baltimore
- Study ID
- NCT07093281
- Phase
- PHASE4
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Impact of Vaccination
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 89 Years
- Healthy Volunteers
- Accepted
Interventions
- Live Attenuated Influenza Vaccine — BIOLOGICALNasal spray
Study Details
The research of the investigators is focused on the understanding how the immune system functions and responds to intranasal vaccines. Intranasal vaccines do not lead to the same changes in the blood that intramuscular vaccines do. Therefore, the investigators want to look at the function of immune (lymphoid) organs that are near the nose. The closest immune organs are the adenoids and tonsils. Mice do not have tonsils allowing for the investigators to answer these questions. Human lymphoid tissue will allow the investigators to better understand the molecular behavior of these cells in humans. The purpose of this protocol is to administer the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and/or tonsillectomy for obstructive sleep apnea prior to surgery and then collect the tissue (adenoid and/or tonsil tissue) that would normally be discarded from surgery. This will allow for improved understanding of what happens after vaccination.
Key Dates
- Start date
- Feb 28, 2026
- Status verified
- Dec 2025
- Primary completion
- Apr 30, 2026
- Completion
- Jul 31, 2026
Study Design
- Enrollment
- 25 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Interventional LAIVIntranasal Flu Vaccine
- No Intervention: No InterventionNo Intervention
Primary Outcome Measure
Serological outcomes will be compared before and after vaccination and between groups. [ Time Frame: From enrollment to 4 weeks after surgery is completed ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21231 |