Intranasal LAIV Mucosal Immunity Examination
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Live Attenuated Influenza Vaccine.
- Who it may be relevant to
- Registry conditions: Impact of Vaccination. Basic parameters: 2 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity
Overview
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.
Interventions
- Biological Live Attenuated Influenza Vaccine
Nasal spray
Primary outcome measures
- Serological outcomes will be compared before and after vaccination and between groups. [Time frame: From enrollment to 4 weeks after surgery is completed]
Secondary outcome measures (4)
- Hemagglutinin Levels [Time frame: From enrollment to 4 weeks after surgery]
- Neuraminidase Levels [Time frame: From enrollment to 4 weeks after surgery]
- Influenza Specific Antibodies [Time frame: From enrollment to 4 weeks after surgery]
- Seroconversion rats [Time frame: From enrollment to 4 weeks post surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of Maryland Medical Center — Baltimore
Identifiers
NCT: NCT07093281 · HP-00114022