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NCT Number: NCT07093281

Intranasal LAIV Mucosal Immunity Examination

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.

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Key information

Age range

2 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21231, United States

Location contact

Adam Kaufman, MD PhD

CONTACT

[email protected]

667-214-2382

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Live attenuated influenza vaccine

Biological

Nasal spray

Primary outcomes

  1. Serological outcomes will be compared before and after vaccination and between groups.

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

    The comparisons will specifically compare:

    Mean HAI Ab titers in serum and mucosal secretions

Secondary outcomes

  1. Hemagglutinin Levels

    Time frame: From enrollment to 4 weeks after surgery

    Mean HA IgG and IgA titers in serum and mucosal secretions

  2. Neuraminidase Levels

    Time frame: From enrollment to 4 weeks after surgery

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

  3. Influenza Specific Antibodies

    Time frame: From enrollment to 4 weeks after surgery

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

  4. Seroconversion rats

    Time frame: From enrollment to 4 weeks post surgery

    Comparison of serconversion rates

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 30, 2025
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.