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Intranasal LAIV Mucosal Immunity Examination

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 11 months later Apr 2026 → Apr 2028
See other at-risk trials from University of Maryland, Baltimore

Record History

  1. Notable Primary completion pushed from Apr 2026 to Apr 2028
    • Start date: Feb 2026 to Feb 2027
    • Study completion pushed from Jul 2026 to Jul 2029
    v4
  2. Notable Start date: Nov 2025 to Feb 2026v3
  3. Notable Start date: Aug 2025 to Nov 2025v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07093281
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)
Impact of Vaccination
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov