Immune Function and Response to Vaccination Following Completion of Cancer Directed Systemic Therapy in Pediatric Patients With Cancer
Wake Forest University Health Sciences
Summary
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.
Description
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,…
Eligibility
- Age range
- 2–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian. 2. Age greater than or equal to 2 years and less than 22 years at the time of consent 3. Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 30 days prior to date of enrollment 4. Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital 5. History of any malignant diagnosis treated with at least one cycle of can…
Interventions
- BiologicalVaccine
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.
Location
- Levine Cancer InstituteCharlotte, North Carolina