Single Booster Versus Full Revaccination After Completion of Cancer Directed Systemic Therapy in Pediatric Cancer Patients with Abnormal Vaccine Antibody Titers

PRIMARY OBJECTIVE:

I. 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.

SECONDARY OBJECTIVES:

I. 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 from last dose of cancer directed systemic therapy.

II. Evaluate infection rates (over a 2-year period post randomization) between subjects with residual immune dysfunction versus subjects with recovered immune function.

III. Evaluate infection rates in enrolled subjects and compare to healthy siblings, when applicable.

IV. Evaluate the prevalence of immune abnormalities at 12 and 24 months as a function of type of malignancy as well as type and length of treatment.

V. Evaluate the prevalence of immune abnormalities as a function of primary vaccination status (completed versus in progress versus vaccine naïve).

SAFETY OBJECTIVE:

I. 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.

OUTLINE: Patients undergo vaccine antibody titer tests at 3 months after completion of standard of care cancer therapy. Patients with normal vaccine titers do not proceed with the study. Patients with abnormal vaccine titers are randomized to 1 of 2 arms.

ARM A: Patients receive Heamophilus influenza B, tetanus, diphtheria, acellular pertussis, inactive polio, and/or hepatitis B vaccines at month 3 if titers at low (below normal range) at baseline. Patients receive measles, mumps rubella and/or varicella vaccines at month 6 if titers at low (below normal range) at baseline. Patients who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine. Patients undergo blood sample collection throughout the study.

ARM B: Patients receive Heamophilus influenza B, tetanus, diphtheria, acellular pertussis, inactive polio, and/or hepatitis B vaccines at months 3, 6, and 9 if titers at low (below normal range) at baseline. Patients receive measles, mumps rubella and/or varicella vaccines at months 6 and 9 if titers at low (below normal range) at baseline. Patients who have negative/undetectable titers to any vaccine at the 24 month visit will receive boosters to each applicable vaccine. Patients undergo blood sample collection throughout the study.

After completion of study treatment, patients are followed up at 30 days.