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Intranasal LAIV Mucosal Immunity Examination

NCT ID: NCT07093281

Last Updated: 2025-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2026-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Impact of Vaccination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Interventional LAIV

Intranasal Flu Vaccine

Group Type EXPERIMENTAL

Live Attenuated Influenza Vaccine

Intervention Type BIOLOGICAL

Nasal spray

No Intervention

No Intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Live Attenuated Influenza Vaccine

Nasal spray

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea

Exclusion Criteria

* Chronic Tonsillitis
* Immune Deficiency
* Already received this year's flu vaccine
Minimum Eligible Age

2 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Maryland, Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Adam Kaufman

Assistant Professor of Otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Facility Contacts

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Adam Kaufman, MD PhD

Role: primary

Other Identifiers

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HP-00114022

Identifier Type: -

Identifier Source: org_study_id