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Intranasal LAIV Mucosal Immunity Examination

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status and phase

Not yet enrolling
Phase 4

Conditions

Impact of Vaccination

Treatments

Biological: Live Attenuated Influenza Vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT07093281
HP-00114022

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

2 to 89 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

25 participants in 2 patient groups

Interventional LAIV
Experimental group
Description:
Intranasal Flu Vaccine
Treatment:
Biological: Live Attenuated Influenza Vaccine
No Intervention
No Intervention group
Description:
No Intervention

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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