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Intranasal LAIV Mucosal Immunity Examination

NCT07093281 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-19

No results posted yet for this study

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

BIOLOGICAL

Live Attenuated Influenza Vaccine

Nasal spray

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-28
Primary Completion
2026-04-30
Completion
2026-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07093281 on ClinicalTrials.gov