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
Wake Forest University Health Sciences
64 participants
Aug 8, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Written informed consent, HIPAA authorization for release of personal health information, and assent, when applicable from the subject, parent, or legal guardian.
- Age greater than or equal to 2 years and less than 22 years at the time of consent
- Lansky/Karnofsky Performance Status of greater than 50 (ECOG less than 2) within 30 days prior to date of enrollment
- Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
- History of any malignant diagnosis treated with at least one cycle of cancer directed systemic therapy
- Must be no more than 60 days from last dose of cancer directed systemic therapy at time of enrollment
- As determined by the enrolling physician, ability of the subject and parent/caregiver to understand and comply with study procedures for the entire length of the study
Exclusion Criteria6
- Malignant disease treated with observation, surgery, or radiotherapy alone
- Known coexisting immunodeficiency
- Subjects with normal baseline titers for all investigated vaccines
- Known pregnancy
- Documented previous severe allergic reaction to any vaccine or component of a vaccine
- Documented current/active, severe infection, as determined by the investigator
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04948619