Intranasal LAIV Mucosal Immunity Examination
The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity
1 other identifier
interventional
25
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2026
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 30, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedDecember 19, 2025
December 1, 2025
2 months
July 14, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Serological outcomes will be compared before and after vaccination and between groups.
The comparisons will specifically compare: Mean HAI Ab titers in serum and mucosal secretions
From enrollment to 4 weeks after surgery is completed
Secondary Outcomes (4)
Hemagglutinin Levels
From enrollment to 4 weeks after surgery
Neuraminidase Levels
From enrollment to 4 weeks after surgery
Influenza Specific Antibodies
From enrollment to 4 weeks after surgery
Seroconversion rats
From enrollment to 4 weeks post surgery
Study Arms (2)
Interventional LAIV
EXPERIMENTALIntranasal Flu Vaccine
No Intervention
NO INTERVENTIONNo Intervention
Interventions
Eligibility Criteria
You may qualify if:
- Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea
You may not qualify if:
- Chronic Tonsillitis
- Immune Deficiency
- Already received this year's flu vaccine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Medical Center
Baltimore, Maryland, 21231, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Otolaryngology
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 30, 2025
Study Start
February 1, 2026
Primary Completion
April 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
December 19, 2025
Record last verified: 2025-12