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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional LAIV | Experimental | Intranasal Flu Vaccine |
|
| No Intervention | No Intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Live Attenuated Influenza Vaccine | Biological | Nasal spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serological outcomes will be compared before and after vaccination and between groups. | The comparisons will specifically compare: Mean HAI Ab titers in serum and mucosal secretions | From enrollment to 4 weeks after surgery is completed |
| Measure | Description | Time Frame |
|---|---|---|
| Hemagglutinin Levels | Mean HA IgG and IgA titers in serum and mucosal secretions | From enrollment to 4 weeks after surgery |
| Neuraminidase Levels | Mean NA IgG and IgA titers in serum and in mucosal secretions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21231 | United States |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| From enrollment to 4 weeks after surgery |
| Influenza Specific Antibodies | Non-neutralizing influenza-specific antibody titers before and after vaccination | From enrollment to 4 weeks after surgery |
| Seroconversion rats | Comparison of serconversion rates | From enrollment to 4 weeks post surgery |