[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100435316":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":54,"collaborators":56,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":23,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":23,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":37,"whyStopped":23,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Wake Forest University Health Sciences","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm A - Single booster vaccines","Those subjects randomized to Arm A, single dose vaccine boosters, will receive non live vaccine boosters at the 3 month visit. Boosters for live vaccines will be given at the 6 month visit. Boosters will only be given as applicable for low titers tested at the baseline assessment visit. Subjects who have negative\u002Fundetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.",[12],"Biological: Vaccine",{"label":14,"type":6,"description":15,"interventionNames":16},"Arm B - Staged revaccination series","Those subjects randomized to Arm B, the full revaccination series, will receive applicable vaccines when titers are low (below normal range) at baseline. When indicated, non-live vaccines will be given at the 3, 6, and 9 month visits, live vaccines will be given at the 6 and 9 month visit. Subjects who have negative\u002Fundetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine.",[12],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL","Vaccine","Patients will have lab evaluations for immune function at baseline, 3, 6, 9 and 24 months post completion of treatment. At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.",[9,14],null,[25],{"name":26,"affiliation":5,"role":27},"Ashley Hinson, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},"Sceria Jenkins, RN","CONTACT","980-442-2323","Sceria.Jenkins@advocatehealth.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Levine Cancer Institute","RECRUITING","Charlotte","North Carolina","28204","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-80.84313,35.22709,{"lat":47,"lon":46},[50,51],{"name":30,"role":31,"phone":32,"phoneExt":23,"email":33},{"name":26,"role":31,"phone":52,"phoneExt":23,"email":53},"704-381-9900","ashley.hinson@advocatehealth.org",{"type":55,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[57],{"name":58,"class":6},"Atrium Health Levine Cancer Institute","100435316","phase-2-immune-function-and-response-to-vaccination-after-cancer-therapy-in-pediatric-patients-100435316",false,"NCT04948619","Immune Function and Response to Vaccination After Cancer Therapy in Pediatric Patients","Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer","Inclusion Criteria:\n\n1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.\n2. Age greater than or equal to 2 years and less than 22 years at the time of consent\n3. Lansky\u002FKarnofsky Performance Status of greater than 50 (ECOG less than 2) within 60 days prior to date of enrollment\u002Frandomization\n4. Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital\n5. History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy\n6. Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment\u002Frandomization\n7. As determined by the enrolling physician, ability of the subject and parent\u002Fcaregiver to understand and comply with study procedures for the entire length of the study\n\nExclusion Criteria:\n\n1. Malignant disease treated with observation, surgery, or radiotherapy alone\n2. Known coexisting immunodeficiency\n3. Subjects with normal baseline titers for all investigated vaccines\n4. Known pregnancy\n5. Documented previous severe allergic reaction to any vaccine or component of a vaccine\n6. Documented current\u002Factive, severe infection, as determined by the investigator","ALL","2 Years","21 Years",{"count":70,"type":71},64,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","Pediatric cancer survivors have increased infection-related morbidity and mortality. This study will evaluate immune dysfunction following cancer directed systemic therapy completion, with attention to clinical relevance and infection rate in this population compared to healthy siblings, when applicable. The investigators will also restart vaccinations at earlier time points than previously studied, at 3 months post therapy, and will assess whether boosters or revaccination schedules are superior for regaining immunity against potentially serious infections in survivors.",[77],"Pediatric Cancer",[79,20],"Pediatric Oncology","2026-07-21",{"date":82,"type":83},"2026-07-23","ACTUAL",{"date":85,"type":83},"2022-08-08",{"date":87,"type":71},"2030-10",{"name":5,"class":6},1]