[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04948619":3,"trial-entities:NCT04948619":96,"trial-summary:NCT04948619":100},{"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":23,"primary_purpose":14,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":89,"overall_officials":91,"references":94,"see_also_links":95},"NCT04948619","IRB00081757","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","RECRUITING","2030-10","2026-07","2026-07-23","2022-08-08","Wake Forest University Health Sciences","OTHER",true,"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.","This study is a prospective, randomized trial. The target population is all patients between the ages of 2 and 21 years of age who complete cancer directed systemic therapy for any malignant diagnosis at our center over a 2 to 3-year time frame. The study will be conducted in the various disease-specific off therapy and survivorship clinics of Levine Children's Cancer and Blood Disorders. Patients will have lab evaluations for immune function at baseline, 3, 6, 12, and 24 months from last dose of cancer directed systemic therapy. At 3 months from last dose of cancer directed systemic 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. Vaccines given will be directed against Haemophilus influenza type B, tetanus, diphtheria, pertussis, polio, hepatitis B, Streptococcus pneumoniae, measles, mumps, rubella, and varicella. Live vaccines (measles, mumps, rubella, and varicella) will be given at 6 months from last dose of cancer directed systemic therapy. Repeat vaccine antibody titers will be assessed at follow up visits as above to determine if there are differences in immediate or maintained immunity based on vaccine strategy used. For subjects \\\u003C18 years of age, we will present health questionnaires to their caregiver to answer at each of the time points. Subjects ≥18 years of age will complete their own health questionnaire. These questionnaires will assess frequency, type, and severity of viral and bacterial infections requiring antibiotics in study patients and their closest healthy sibling in age, when applicable.",[19],"Pediatric Cancer",[21,22],"Pediatric Oncology","Vaccine","INTERVENTIONAL",[25],"PHASE2",{"count":27,"type":28},64,"ESTIMATED",[30],{"type":31,"name":22,"description":32,"armGroupLabels":33},"BIOLOGICAL","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.",[34,35],"Arm A - Single booster vaccines","Arm B - Staged revaccination series",[37],{"measure":38,"description":39,"timeFrame":40},"Vaccination comparison via objective lab measurements of vaccine titers","To compare single booster vaccination (Arm A) to full revaccination (Arm B) in terms of immune response at 24 months post cancer directed systemic therapy in pediatric subjects who have received cancer directed systemic therapy for any malignancy.","2 years",[42,46,49,52,55],{"measure":43,"description":44,"timeFrame":45},"Vaccine comparison at 12 & 24 months","To compare single booster vaccination to full revaccination in pediatric subjects who have received cancer directed systemic therapy for any malignancy in terms of the prevalence of immune abnormalities at 12 and 24 months completion.","Up to 2 years",{"measure":47,"description":48,"timeFrame":45},"Infection Rates","Evaluate infection rates (over a 2-year post randomization period) between subjects with residual immune dysfunction versus subjects with recovered immune function",{"measure":50,"description":51,"timeFrame":45},"Healthy Sibling comparison","Evaluate infection rates in enrolled subjects and compare to healthy siblings, when applicable",{"measure":53,"description":54,"timeFrame":45},"Immune Abnormalities - Malignancy","Evaluate the prevalence of immune abnormalities at 12 and 24 months as a function of type of malignancy and length of treatment",{"measure":56,"description":57,"timeFrame":45},"Immune Abnormalities - Primary Vaccination Status","Evaluate the prevalence of immune abnormalities as a function of primary vaccination status","ALL","2 Years","21 Years",false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"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",[67,68],"CHILD","ADULT",[70],{"facility":71,"status":8,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":86},"Levine Cancer Institute","Charlotte","North Carolina","28204","United States",[77,82],{"name":78,"role":79,"phone":80,"email":81},"Sceria Jenkins, RN","CONTACT","980-442-2323","Sceria.Jenkins@advocatehealth.org",{"name":83,"role":79,"phone":84,"email":85},"Ashley Hinson, MD","704-381-9900","ashley.hinson@advocatehealth.org",{"lat":87,"lon":88},35.22709,-80.84313,[90],{"name":78,"role":79,"phone":80,"email":81},[92],{"name":83,"affiliation":13,"role":93},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":97,"biomarkers":99},[98],"Malignant Neoplasm",[],{"nct_id":4,"found":15,"summary":101,"prompt_version":111},{"design":102,"status":103,"heading":104,"summary":105,"follow_up":106,"word_count":107,"commitments":108,"compensation":109,"drugs_mentioned":110},"This is a randomized study planning to enroll 64 participants. It will compare two different vaccination strategies.","completed","Immune Function and Vaccination After Pediatric Cancer Therapy","This study is for children and young adults aged 2 to 21 who have completed cancer treatment. It aims to understand how cancer therapy affects their immune system and their ability to fight infections. Researchers will evaluate immune function and vaccine protection over 2 years. If your child's vaccine protection is low, they will either receive booster vaccines or a full series of revaccinations (like those given after a stem cell transplant) using vaccines for diseases like Haemophilus influenza type B, tetanus, polio, and measles. The study will compare these two approaches to see which is better at restoring immunity. The goal is to improve protection against serious infections in pediatric cancer survivors.","Participants will be followed for 2 years to assess vaccine protection.",113,"Participants will have lab evaluations for immune function at baseline, 3, 6, 9, and 24 months after finishing cancer treatment. Some participants will receive booster vaccines or a full revaccination series.","Not stated in the trial record.",[22],"v2"]