Vaccinating Children After Chemotherapy
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Rationale and Aims: Children with acute lymphoblastic leukemia (ALL) have evidence of
      persistent immunosuppression following chemotherapy and may experience waning of immunity to
      vaccines received prior to treatment. There is no standard of care in Canada regarding
      immunologic evaluation or booster immunization of children with ALL after chemotherapy. This
      study aims to identify predictors of low baseline immunity to vaccine antigens in children
      with ALL and to evaluate the immunogenicity and safety of a standard immunization regimen:
      DTaP-IPV-Hib and PCV13 booster immunization administered 6 months post-chemotherapy, followed
      by PPV23.

      Study Design: This will be a multi-center open-label clinical trial in which children who
      were diagnosed with ALL at ≥1 year of age, and have not received immunizations other than
      influenza since completing chemotherapy will undergo immunologic evaluation and serologic
      testing for pneumococcus, tetanus, pertussis and varicella. They will then be immunized with
      PCV13, DTaP-IPV-Hib, regardless of immunization history [unless PPV23 was received within the
      prior 12 months]. Other routine vaccines required as per provincial and centre-specific
      immunization policies will also be administered. PPV23 will be administered 8 weeks after
      PCV13. Repeat serologic testing will be conducted at 2 months and 12-15 months after
      DTaP-IPV-Hib and PCV13 immunization to assess short and long-term immune responses.

      Adverse events following immunization (AEFI) will be captured through standardized telephone
      interviews on days 8-10 and 30-33 post-immunization that will capture local and systemic
      AEFI.
    

Intervention name(s): Prevnar®13; Pneumovax® 23; Pediacel®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 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.
Other intervention name(s): 13- valent conjugate pneumococcal vaccine; PCV13; 23-valent polysaccharide pneumococcal vaccine; PPV23; DTaP-IPV-Hib
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention