CClinicalTrials.gg
Not yet recruitingNCT07093281Updated Sep 3, 2026

Intranasal LAIV Mucosal Immunity Examination

A Phase 4 interventional study of Live Attenuated Influenza Vaccine in Impact of Vaccination, sponsored by University of Maryland, Baltimore. Not yet recruiting at 1 site in United States. Open to participants aged 2 Years to 89 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
2 Years to 89 Years
Sex
All
01

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.

02

Conditions studied

  • Impact of Vaccination
03

In context

Lead sponsor

University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.

Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chronic Tonsillitis
  • Immune Deficiency
  • Already received this year's flu vaccine
05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Interventional LAIV

    Intranasal Flu Vaccine

    Biological: Live Attenuated Influenza Vaccine

  • No intervention
    No Intervention

    No Intervention

Interventions

  • BiologicalLive Attenuated Influenza Vaccine

    Nasal spray

06

What researchers measure

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

    Time frame: From enrollment to 4 weeks after surgery is completed

Secondary outcomes

  1. Hemagglutinin Levels

    Mean HA IgG and IgA titers in serum and mucosal secretions

    Time frame: From enrollment to 4 weeks after surgery

  2. Neuraminidase Levels

    Mean NA IgG and IgA titers in serum and in mucosal secretions

    Time frame: From enrollment to 4 weeks after surgery

  3. Influenza Specific Antibodies

    Non-neutralizing influenza-specific antibody titers before and after vaccination

    Time frame: From enrollment to 4 weeks after surgery

  4. Seroconversion rats

    Comparison of serconversion rates

    Time frame: From enrollment to 4 weeks post surgery

07

Study locations

1 site
  • University of Maryland Medical Center
    Baltimore, Maryland 21231, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07093281
Lead sponsor
University of Maryland, Baltimore
Responsible party
Adam Kaufman (Assistant Professor of Otolaryngology, University of Maryland, Baltimore) — Principal investigator
First posted
Jul 30, 2025
Start date
Feb 2027 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Jul 2029 (estimated)
Last update
Sep 3, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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