Clinical trial · Interventional
Vaccinating Children After Chemotherapy
Vaccinating Children After Chemotherapy for Acute Lymphoblastic Leukemia: A Canadian Immunization Research Network Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pediacel® | Biological | — | UNRESOLVED |
| Pneumovax® 23 | Biological | — | UNRESOLVED |
| Prevnar®13 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Experimental
- description
- 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.
- interventionNames
- Biological: Prevnar®13
- Biological: Pneumovax® 23
- Biological: Pediacel®
- type
- NO_INTERVENTION
- label
- Healthy Control
- description
- Children 3-18 years of age who are not immunocompromised age-matched to cases from Group 1.
Primary outcomes (1)
- measure
- Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDTop 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 32067048