Impact of Vaccination
Conditions
Brief 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.
Interventions
BIOLOGICALLive Attenuated Influenza Vaccine
Nasal spray
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 89 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serological outcomes will be compared before and after vaccination and between groups. | From enrollment to 4 weeks after surgery is completed | The comparisons will specifically compare: Mean HAI Ab titers in serum and mucosal secretions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Influenza Specific Antibodies | From enrollment to 4 weeks after surgery | Non-neutralizing influenza-specific antibody titers before and after vaccination |
| Seroconversion rats | From enrollment to 4 weeks post surgery | Comparison of serconversion rates |
| Hemagglutinin Levels | From enrollment to 4 weeks after surgery | Mean HA IgG and IgA titers in serum and mucosal secretions |
| Neuraminidase Levels | From enrollment to 4 weeks after surgery | Mean NA IgG and IgA titers in serum and in mucosal secretions |
Countries
United States
Outcome results
None listed