[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07726862":3,"trial-entities:NCT07726862":98,"trial-summary:NCT07726862":102},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":44,"healthy_volunteers":45,"eligibility_criteria":46,"std_ages":71,"locations":74,"central_contacts":89,"overall_officials":91,"references":96,"see_also_links":97},"NCT07726862","IRB-300016968","How Healthy Adults Respond to the Nasal Flu Vaccine","Characterizing Local Mucosal Responses to Live Attenuated Influenza Vaccine in Healthy Adults","NOT_YET_RECRUITING","2031-06-30","2026-06","2026-07-24","2026-10-01","University of Alabama at Birmingham","OTHER",null,"This study is looking at how the immune system in the nose responds after receiving the FluMist nasal flu vaccine in healthy adults. FluMist is an FDA-approved influenza vaccine that is given as a nasal spray.\n\nHealthy volunteers aged 18 to 65 who do not have chronic medical conditions, do not smoke, and have not recently received a flu vaccine will be enrolled. Participants will have three study visits over approximately one week. At the first visit, participants will be screened, give informed consent, and receive the FluMist vaccine. Nasal swabs and a gentle saline nasal wash will be collected before vaccination and again at two and four days after vaccination.\n\nThe samples collected will be used to study changes in immune cells, proteins, and viral activity in the nose using laboratory techniques such as gene expression and protein analysis. This information may help researchers better understand how flu vaccines work at the site where infection begins and may support the development of improved vaccines in the future.\n\nThere is no direct medical benefit expected for participants. Participation is voluntary, and all study procedures will be performed by trained clinical staff.","This is a prospective interventional study evaluating mucosal immune and epithelial responses in healthy adults following administration of the FDA-approved live attenuated influenza vaccine (FluMist) given as an intranasal spray. Healthy volunteers aged 18 to 65 years who do not smoke and who meet eligibility criteria will be enrolled.\n\nParticipants will complete three study visits over approximately one week. At the first visit, informed consent, screening, baseline nasal swabs and nasal wash will be performed, followed by administration of FluMist. Follow-up nasal samples and safety assessments will be collected at approximately 2 and 4 days after vaccination.\n\nNasal samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess local immune, epithelial, and viral responses. Samples will be coded, stored under secure conditions, and retained for up to five years after study completion.\n\nThe objective of the study is to characterize early mucosal immune responses to FluMist vaccination and improve understanding of influenza vaccine-induced immunity at the site of infection.",[19],"Mucosal Immune Response to Influenza Vaccination",[21],"FluMist, LAIV, influenza vaccine, mucosal immunity, nasal immune response, intranasal vaccine, healthy volunteers, nasal swab, proteomics","INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE4",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BIOLOGICAL","FluMist (Live Attenuated Influenza Vaccine)","FluMist is an FDA-approved live attenuated influenza vaccine administered as a nasal spray. Participants will receive a single standard dose of FluMist intranasally, with half the dose administered into each nostril by trained study personnel according to manufacturer instructions. The vaccine is used in this study to evaluate local mucosal and immune responses in the nasal cavity.",[35],"Healthy Adults Receiving Intranasal FluMist Vaccination",[37],{"measure":38,"description":39,"timeFrame":40},"Change in Nasal Mucosal Immune Response Following FluMist Vaccination","This outcome measure evaluates changes in the nasal mucosal immune and epithelial response following administration of the intranasal live attenuated influenza vaccine (FluMist). Nasal swab and nasal wash samples will be collected at baseline (pre-vaccination) and at approximately 2 and 4 days post-vaccination. Samples will be analyzed using single-cell RNA sequencing, proteomics, and RT-qPCR to assess changes in immune cell populations, gene expression profiles, protein expression, and viral activity over time.","Baseline through 4 days post-vaccination",[],"ALL","18 Years","65 Years",true,{"inclusion":47,"exclusion":55,"raw_text":70},[48,49,50,51,52,53,54],"Healthy adults aged 18 to 65 years","Non-smokers (no smoking or vaping within the past 6 months)","No chronic lung disease or significant chronic medical conditions","No current or recent (within 1 month) upper or lower respiratory infection","Able and willing to provide informed consent","Have not received the current seasonal influenza vaccine","Able to comply with study procedures and follow-up visits",[56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Age under 18 or over 65 years","Pregnancy or breastfeeding","Prisoners","Non-English speaking individuals","Immunocompromised individuals (including HIV\u002FAIDS, immunosuppressive therapy, chemotherapy, or primary immunodeficiency)","Chronic medical conditions including asthma, chronic lung, liver, kidney, neurologic, hematologic, metabolic, or significant cardiovascular disease (except isolated hypertension)","History of chronic sinusitis or significant nasal allergies requiring frequent or daily treatment","Acute moderate or severe illness at time of enrollment, with or without fever","Receipt of influenza vaccine during the current season or within the past 2 weeks","Receipt of another live vaccine within 4 weeks prior to enrollment or planned during study period","Use of influenza antiviral medications (e.g., oseltamivir, zanamivir) within 48 hours prior to vaccination or planned use within 14 days after vaccination","History of severe allergic reaction to influenza vaccine or any component of FluMist (including egg allergy if applicable)","History of Guillain-Barré syndrome following influenza vaccination","Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results","Inclusion Criteria:\n\n* Healthy adults aged 18 to 65 years\n* Non-smokers (no smoking or vaping within the past 6 months)\n* No chronic lung disease or significant chronic medical conditions\n* No current or recent (within 1 month) upper or lower respiratory infection\n* Able and willing to provide informed consent\n* Have not received the current seasonal influenza vaccine\n* Able to comply with study procedures and follow-up visits\n\nExclusion Criteria:\n\n* Age under 18 or over 65 years\n* Pregnancy or breastfeeding\n* Prisoners\n* Non-English speaking individuals\n* Immunocompromised individuals (including HIV\u002FAIDS, immunosuppressive therapy, chemotherapy, or primary immunodeficiency)\n* Chronic medical conditions including asthma, chronic lung, liver, kidney, neurologic, hematologic, metabolic, or significant cardiovascular disease (except isolated hypertension)\n* History of chronic sinusitis or significant nasal allergies requiring frequent or daily treatment\n* Acute moderate or severe illness at time of enrollment, with or without fever\n* Receipt of influenza vaccine during the current season or within the past 2 weeks\n* Receipt of another live vaccine within 4 weeks prior to enrollment or planned during study period\n* Use of influenza antiviral medications (e.g., oseltamivir, zanamivir) within 48 hours prior to vaccination or planned use within 14 days after vaccination\n* History of severe allergic reaction to influenza vaccine or any component of FluMist (including egg allergy if applicable)\n* History of Guillain-Barré syndrome following influenza vaccination\n* Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":86},"Birmingham","Alabama","35294","United States",[81],{"name":82,"role":83,"phone":84,"email":85},"Shanna H Graves, AAS","CONTACT","205-975-2845","shannagraves@uabmc.edu",{"lat":87,"lon":88},33.52066,-86.80249,[90],{"name":82,"role":83,"phone":84,"email":85},[92],{"name":93,"affiliation":94,"role":95},"Kevin S Harrod, PhD","UAB All Study (Central)","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":101},[100],"Healthy Volunteers",[],{"nct_id":4,"found":45,"summary":103,"prompt_version":112},{"design":104,"status":105,"heading":6,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is an interventional study with 20 healthy adult participants. It is designed to observe how the body responds to the FluMist vaccine.","completed","This study is looking at how your immune system in the nose responds after you receive the FluMist nasal flu vaccine. FluMist is an FDA-approved flu vaccine given as a nasal spray. We are enrolling healthy adults aged 18 to 65 who do not smoke, have no chronic medical conditions, and have not recently received a flu vaccine. The main goal is to see how your nasal immune response changes from before vaccination to four days after receiving FluMist. This study is currently unclear on its recruitment status and plans to enroll 20 participants.","Your nasal immune response will be measured from before vaccination through 4 days after vaccination.",94,"You would have three study visits over about one week. These visits include screening, giving consent, receiving the FluMist vaccine, and having nasal swabs and a gentle saline nasal wash collected.","Not stated in the trial record.",[],"v2"]