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Vaccinating Children After Chemotherapy

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ClinicalTrials.gov Identifier: NCT02447718
Recruitment Status : Active, not recruiting
First Posted : May 19, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Karina Top, Canadian Immunization Research Network

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Biological: Prevnar®13 Biological: Pneumovax® 23 Biological: Pediacel® Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study
Study Start Date : November 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019


Arm Intervention/treatment
Active Comparator: Experimental
Children who were diagnosed with ALL at ≥1 year of age, and are within 6-8 months of completing chemotherapy will receive 1 dose each of: Prevnar®13 and Pediacel® vaccines, followed by 1 dose of Pneumovax® 23 given 2 months after PCV13.
Biological: Prevnar®13
A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Other Names:
  • 13- valent conjugate pneumococcal vaccine
  • PCV13

Biological: Pneumovax® 23
A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
Other Names:
  • 23-valent polysaccharide pneumococcal vaccine
  • PPV23

Biological: Pediacel®
A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Other Name: DTaP-IPV-Hib

No Intervention: Healthy Control
Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.



Primary Outcome Measures :
  1. Proportion of participants with protective titres to PCV13 serotypes post-immunization with PCV13+PPV23 [ Time Frame: 12-15 months ]
    The proportion of participants with protective titres (≥0.35 ug/ml) to PCV13 serotypes will be assessed at 2 months and 12-15 months post PCV13+PPV23 and compared to baseline levels.


Secondary Outcome Measures :
  1. Proportion of participants with protective titres to PCV13 serotypes at baseline [ Time Frame: Day 0 ]
    The proportion of participants with protective titres (≥0.35 ug/ml) to PCV13 serotypes at baseline will be compared to age-matched controls.

  2. Baseline antibody titres in subjects with ALL versus controls [ Time Frame: Day 0 ]
    Baseline geometric mean titers (GMT) and proportion of subjects with protective titres to varicella, pertussis toxin, and tetanus will be assessed in children with ALL versus age-matched controls.

  3. Immune responses to DTaP-IPV-Hib booster vaccination [ Time Frame: 12-15 months ]
    Short-term (baseline to 2 months after vaccination) and long-term (baseline to 12-15 months) vaccine responses to DTaP will be measured using GMT ratios.


Other Outcome Measures:
  1. Safety assessed by frequency of AEFI requiring healthcare visit or leading to >=1 day of disability will be reported after each vaccination [ Time Frame: 30 days ]
    AEFI will be captured through structured telephone interviews on days 8-10 and 30-33 after each immunization



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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02447718


Locations
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Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
Canadian Immunization Research Network
Investigators
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Principal Investigator: Karina Top, MD, MS Dalhousie University

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Responsible Party: Karina Top, Principal Investigator, Canadian Immunization Research Network
ClinicalTrials.gov Identifier: NCT02447718     History of Changes
Other Study ID Numbers: SI02
First Posted: May 19, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs