Vaccinating Children After Chemotherapy
1 other identifier
interventional
156
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2015
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedStudy Start
First participant enrolled
November 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2018
CompletedResults Posted
Study results publicly available
February 4, 2021
CompletedJune 24, 2022
June 1, 2022
2.3 years
May 13, 2015
October 8, 2020
June 22, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23
The percentage of participants with protective titres (with protective level defined as ≥0.35 ug/ml, as per World Health Organization criteria) to PCV13 serotypes will be assessed at 2 months and 12-15 months post PCV13+PPV23 and compared to baseline levels.
Pre-vaccination Baseline, 2 months and 12-15 months
Secondary Outcomes (7)
Number of Participants With Protective Titres to PCV7 Serotypes at Baseline
Day 0
Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls
Day 0
Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination
Prevaccination baseline, 2 months, 12-15 months
Baseline Tetanus Toxoid Antibody Titers in Children With ALL Versus Controls
Day 0
Baseline Pertussis Toxin Titers in Children With ALL Versus Healthy Controls
Day 0
- +2 more secondary outcomes
Other Outcomes (1)
Number of Participants With Adverse Events Following Immunization Requiring Healthcare Visit or Leading to >=1 Day of Disability
days 8-10 and 30-33
Study Arms (2)
Experimental
ACTIVE COMPARATORChildren 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.
Healthy Control
NO INTERVENTIONChildren 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8, Canada
Related Publications (1)
Top KA, Vaudry W, Morris SK, Pham-Huy A, Pernica JM, Tapiero 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 Dec 3;71(9):e439-e448. doi: 10.1093/cid/ciaa163.
PMID: 32067048DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Antibody levels to vaccine antigens were not measured before chemotherapy, cannot confirm that chemotherapy was the cause of low postchemotherapy titers. 2. Immunization status at ALL diagnosis was not assessed and therefore could not confirm whether postchemotherapy participants were underimmunized for age before diagnosis relative to their peers. 3. We were unable to assess antibodies to other pertussis antigens (eg, filamentous hemagglutinin, pertactin), only anti-PT antibodies alone.
Results Point of Contact
- Title
- Dr. Karina Top
- Organization
- IWK Health Centre
Study Officials
- PRINCIPAL INVESTIGATOR
Karina Top, MD, MS
Dalhousie University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 19, 2015
Study Start
November 16, 2015
Primary Completion
March 5, 2018
Study Completion
March 5, 2018
Last Updated
June 24, 2022
Results First Posted
February 4, 2021
Record last verified: 2022-06