NCT07093281

Intranasal LAIV Mucosal Immunity Examination

The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 2 Years – 89 Years
• Healthy volunteers: Accepted

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.

Conditions

• Impact of Vaccination

Interventions

Type	Name	Description
BIOLOGICAL	Live Attenuated Influenza Vaccine	Nasal spray

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-04-01
• Completion: 2026-07-01
• First posted: 2025-07-30
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study