Intranasal LAIV Mucosal Immunity Examination

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07093281
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Impact of Vaccination

Eligibility Criteria

Sex
ALL
Age
2 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Live Attenuated Influenza Vaccine — BIOLOGICAL
    Nasal spray

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Interventional LAIV
    Intranasal Flu Vaccine
  • No Intervention: No Intervention
    No Intervention

Primary Outcome Measure

Serological outcomes will be compared before and after vaccination and between groups. [ Time Frame: From enrollment to 4 weeks after surgery is completed ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Medical CenterBaltimoreMaryland21231
Adam Kaufman, MD PhD
667-214-2382

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