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Vaccinating Children After Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02447718
Recruitment Status : Unknown
Verified November 2018 by Karina Top, Canadian Immunization Research Network.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE May 19, 2015
Last Update Posted Date November 6, 2018
Study Start Date  ICMJE November 2015
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2015)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 14, 2015)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Vaccinating Children After Chemotherapy
Official Title  ICMJE Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Acute Lymphoblastic Leukemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: Prevnar®13
    • Biological: Pneumovax® 23
    • Biological: Pediacel®
  • No Intervention: Healthy Control
    Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
Publications * Top KA, Vaudry W, Morris SK, Pham-Huy A, Pernica JM, Tapiéro B, Gantt S, Price VE, Rassekh SR, Sung L, McConnell A, Rubin E, Chawla R, Halperin SA. Waning vaccine immunity and vaccination responses in children treated for acute lymphoblastic leukemia: A Canadian Immunization Research Network Study. Clin Infect Dis. 2020 Feb 18. pii: ciaa163. doi: 10.1093/cid/ciaa163. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: November 5, 2018)
154
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2015)
200
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02447718
Other Study ID Numbers  ICMJE SI02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Karina Top, Canadian Immunization Research Network
Study Sponsor  ICMJE Canadian Immunization Research Network
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karina Top, MD, MS Dalhousie University
PRS Account Canadian Immunization Research Network
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP