[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525990":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":26,"studyPopulation":17,"armGroups":27,"interventions":33,"overallOfficials":38,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":69,"id":73,"slug":17,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":17,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":17,"enrollmentInfo":81,"targetDuration":17,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":51,"whyStopped":17,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Pneumococcal Opsonophagocytic Killing Activity (OPH) by neutrophils from young versus old donors at 1 week and 1 month after vaccination","OPH will be determined by measuring the percentage of S. pneumoniae bacteria killed in vitro by neutrophils from donors","1 month",[14],{"measure":15,"description":16,"timeFrame":12},"Surface phenotype of neutrophils from young versus old donors at 1 week and 1 month after vaccination","Phenotype will be determined by measuring the expression of surface receptors on neutrophils ex vivo by flowcytometry from donors",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":21,"primaryPurpose":22,"observationalModel":17,"timePerspective":17,"maskingInfo":23},"NA","SINGLE_GROUP","Vaccination with Prevnar.","BASIC_SCIENCE",{"masking":24,"maskingDescription":25,"whoMasked":17},"NONE","Enrolled participants will be assigned a unique study identification number followed by a visit number (example 1.1 for donor #1-first visit). The code list, linking patient identities (such as names\u002Fphone numbers) and samples, will be kept in a separate file locked in a drawer the PI's office. The code list and code-identified data will be stored in separate locations and only authorized individuals will have access to the list. Experiments and data analysis will be performed only on coded samples and researchers will only have access to the visit number as the experiments to be performed on the collected samples pre and post vaccination differ.","This study focuses on the role of neutrophils in shaping the adaptive immune response to the anti-pneumococcal vaccine Prevnar in young and elderly adults. This study involves direct vaccination of human volunteers. The endpoints will be determining how vaccination affects neutrophil responses and linking those neutrophil responses to antibody responses following vaccination. The main results will be:\n\n1. Elucidating how neutrophils kill bacteria before and after vaccination\n2. Elucidate the phenotype of neutrophils before and after vaccination\n3. Elucidate how neutrophils interact with B and T cell in vitro before and after vaccination\n4. Measure antibody levels and function before and after vaccination\n5. Correlate neutrophil responses to antibody levels and function",[28],{"label":21,"type":29,"description":30,"interventionNames":31},"EXPERIMENTAL","Intramuscular vaccination with Prevnar 20",[32],"Other: vaccine",[34],{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"vaccine","Vaccination against 20 serotypes of S. pneumoniae",[21],[39],{"name":40,"affiliation":41,"role":42},"Elsa N Bou Ghanem, PhD","University at Buffalo","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":17,"email":48},"Elsa Bou Ghanem, PhD","CONTACT","7168292422","elsaboug@buffalo.edu",[50],{"facility":41,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Buffalo","New York","14203","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-78.87837,42.88645,{"lat":61,"lon":60},[64],{"name":65,"role":46,"phone":17,"phoneExt":17,"email":17},"Catherine Wrona",{"type":42,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Elsa Bou Ghanem","Principal Investigator",[70],{"name":71,"class":72},"National Institute on Aging (NIA)","NIH","100525990",false,"NCT06128915","The Role of Neutrophils in the Age-driven Decline in Anti-pneumococcal Vaccine Responses","Inclusion Criteria:\n\n* Both sexes\n* Have not been vaccinated with any licensed or experimental pneumococcal vaccine\n* Ages 21-40; and ≥65. Individuals \\>60 years old will also be recruited in case we find no unvaccinated people ≥65 years old\n* Free of acute infections within the last 2 weeks\n* Did not take any anti-inflammatory medicine in the last week\n* Did not ingest alcohol in the last 24 hours\n* Ability and willingness to provide consent\n\nExclusion Criteria:\n\n* Previous vaccination with any licensed or experimental pneumococcal vaccine\n* Known hypersensitivity to vaccination and vaccine components\n* Immune deficiency\n* Use of immune-modulating or suppressive drugs\n* Malignancies within the last 2 years\n* Known hematological, rheumatic and inflammatory diseases\n* Known chronic infections\n* Poorly controlled chronic cardiovascular and metabolic conditions\n* Pregnancy\n* Dementia",true,"ALL","21 Years",{"count":82,"type":83},60,"ESTIMATED","INTERVENTIONAL",[86],"PHASE4","This study focuses on the role of neutrophils in shaping the adaptive immune response to the anti-pneumococcal vaccine Prevnar-13 in young and elderly adults.",[89],"Aging",[89,91,92,93],"Neutrophils","Streptococcus pneumoniae","Pneumococcal conjugate vaccine","2026-04-02",{"date":96,"type":97},"2026-04-03","ACTUAL",{"date":99,"type":97},"2024-01-08",{"date":101,"type":83},"2027-05-31",{"name":5,"class":6},1]