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.
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 60 days prior to date of enrollment/randomization
Histological or cytological confirmation of any malignancy treated by the Pediatric Oncology team of Levine Children's Hospital
Malignant disease treated with observation, surgery, or radiotherapy alone
Known coexisting immunodeficiency
Subjects with normal baseline titers for all investigated vaccines
Known pregnancy
Parallel
Vaccine
Biological/VaccinePatients 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.
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.
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.
Infection Rates
Evaluate infection rates (over a 2-year post randomization period) between subjects with residual immune dysfunction versus subjects with recovered immune function
Healthy Sibling comparison
Evaluate infection rates in enrolled subjects and compare to healthy siblings, when applicable
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
Safety - Potential Side Effects
To summarize the rates of potential side effects thought by the investigator to be related to each vaccine strategy, including fever, rash, myalgias, injection site reaction, infection, or anaphylaxis.
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Wake Forest University Health Sciences
Lead sponsor
Atrium Health Levine Cancer Institute
Collaborator
