Vaccinating Children After Chemotherapy
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Prevnar®13; Pneumovax® 23; Pediacel®
Intervention description: A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.; A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13; A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 156.0
Sex: All
Minimum age: 3 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This multi-center open label clinical trial aims to identify predictors of low antibody
      titers to vaccine antigens in children with ALL who completed chemotherapy in the prior 6
      months, and to determine the immunogenicity and safety of diphtheria-tetanus-acellular
      pertussis-inactivated poliomyelitis-Haemophilus influenzae type b (DTaP-IPV-Hib) and
      13-valent pneumococcal conjugate vaccine (PCV13) booster immunization administered 6 months
      post-chemotherapy, followed by 23-valent pneumococcal polysaccharide vaccination (PPV23) 2
      months later. The results will support the development of clinical practice guidelines for
      this population.
    

Eligibility criteria:

        Cases with ALL:

        Inclusion Criteria:

          -  Diagnosed with standard, high-risk or very-high risk ALL

          -  Age at diagnosis: ≥1 year of age (age at enrollment: ≥3 years)

          -  Completed chemotherapy 3 to 12 months prior to enrollment

          -  No evidence of ALL relapse or secondary malignancy

          -  No known primary immunodeficiency

          -  No receipt of pneumococcal or tetanus-containing vaccines since completing
             chemotherapy

          -  No history of allergy to any component of PCV13

          -  Caregiver and/or participant is English or French-speaking and able to provide written
             informed consent

        Exclusion Criteria:

          -  Infantile ALL

          -  Evidence of disease relapse or secondary malignancy

          -  History of underlying primary immunodeficiency

          -  Transplant recipient

          -  Received intravenous immunoglobulin (IVIG) within past 9 months or other blood
             products within the prior 3 months.Children who received PPV23 within 12 months of
             enrollment will not be eligible to receive PCV13 or PPV23. These children can still
             participate in the baseline evaluation, receive DTaP-Hib-IPV vaccine, and have tetanus
             and pertussis serology measured at 2 and 12-15 months post-immunization.

        Controls:

        Inclusion criteria

          -  Children 3-18 years of age, age-matched to cases

          -  Caregiver and/or participant is English or French-speaking and able to provide written
             informed consent

        Exclusion criteria

          -  History of primary or secondary immunodeficiency including aplastic anemia,
             malignancy, nephrotic syndrome, malabsorption or severe malnutrition

          -  Immunosuppressive therapy within 3 months of enrollment (excluding inhaled
             corticosteroids)

          -  Received intravenous immunoglobulin (IVIG) within past 9 months or other blood
             products within the prior 3 months.