[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07093281":3,"trial-entities:NCT07093281":91,"trial-summary:NCT07093281":95},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":67,"locations":71,"central_contacts":87,"overall_officials":88,"references":89,"see_also_links":90},"NCT07093281","HP-00114022","Intranasal LAIV Mucosal Immunity Examination","The Impact of Live Attenuated Intranasal Influenza Vaccine Exposure on Mucosal Immunity","NOT_YET_RECRUITING","2026-07","2025-12","2025-12-19","2026-02","University of Maryland, Baltimore","OTHER",false,"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.\n\nThe purpose of this protocol is to administer the FDA approved live attenuated influenza vaccine or no vaccine to patients undergoing adenoidectomy and\u002For tonsillectomy for obstructive sleep apnea prior to surgery and then collect the tissue (adenoid and\u002For tonsil tissue) that would normally be discarded from surgery. This will allow for improved understanding of what happens after vaccination.",null,[19],"Impact of Vaccination",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"PHASE4",{"count":26,"type":27},25,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BIOLOGICAL","Live Attenuated Influenza Vaccine","Nasal spray",[34],"Interventional LAIV",[36],{"measure":37,"description":38,"timeFrame":39},"Serological outcomes will be compared before and after vaccination and between groups.","The comparisons will specifically compare:\n\nMean HAI Ab titers in serum and mucosal secretions","From enrollment to 4 weeks after surgery is completed",[41,45,48,51],{"measure":42,"description":43,"timeFrame":44},"Hemagglutinin Levels","Mean HA IgG and IgA titers in serum and mucosal secretions","From enrollment to 4 weeks after surgery",{"measure":46,"description":47,"timeFrame":44},"Neuraminidase Levels","Mean NA IgG and IgA titers in serum and in mucosal secretions",{"measure":49,"description":50,"timeFrame":44},"Influenza Specific Antibodies","Non-neutralizing influenza-specific antibody titers before and after vaccination",{"measure":52,"description":53,"timeFrame":54},"Seroconversion rats","Comparison of serconversion rates","From enrollment to 4 weeks post surgery","ALL","2 Years","89 Years",true,{"inclusion":60,"exclusion":62,"raw_text":66},[61],"Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea",[63,64,65],"Chronic Tonsillitis","Immune Deficiency","Already received this year's flu vaccine","Inclusion Criteria:\n\n* Patient undergoing tonsillectomy and adenoidectomy as part of the standard of care for sleep apnea\n\nExclusion Criteria:\n\n* Chronic Tonsillitis\n* Immune Deficiency\n* Already received this year's flu vaccine",[68,69,70],"CHILD","ADULT","OLDER_ADULT",[72],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":84},"University of Maryland Medical Center","Baltimore","Maryland","21231","United States",[79],{"name":80,"role":81,"phone":82,"email":83},"Adam Kaufman, MD PhD","CONTACT","667-214-2382","adam.kaufman@som.umaryland.edu",{"lat":85,"lon":86},39.29038,-76.61219,[],[],[],[],{"nct_id":4,"conditions":92,"biomarkers":94},[93],"Obstructive Sleep Apnea",[],{"nct_id":4,"found":58,"summary":96,"prompt_version":105},{"design":97,"status":98,"heading":6,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an interventional study, meaning participants will receive a specific treatment (the nasal spray vaccine). It plans to include 25 participants.","completed","This study is looking at how the immune system (your body's defense against illness) responds to a nasal spray flu vaccine called Live Attenuated Influenza Vaccine (LAIV). Researchers want to understand why this type of vaccine doesn't cause the same changes in the blood as shots do. They will study immune organs near the nose, like tonsils and adenoids, from people having surgery for sleep apnea. The goal is to see how your body's immune response changes after vaccination by comparing blood tests before and after. This study is for people aged 2 to 89 who are having tonsillectomy and adenoidectomy, and who haven't had this year's flu vaccine. The study is currently unclear on its recruitment status and plans to enroll 25 participants.","Your immune response will be measured from enrollment up to 4 weeks after your surgery is completed.",124,"You would receive the Live Attenuated Influenza Vaccine (LAIV) nasal spray. Blood tests will be taken before and after vaccination.","Not stated in the trial record.",[31],"v2"]