Phase 4
N=156
Vaccinating Children After Chemotherapy
Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02447718 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23 — 40; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Prevnar®13 (Biological); Pneumovax® 23 (Biological); Pediacel® (Biological)
- Age
- Pediatric, Adult · 3+ yrs
- Sex
- All
- Sponsor
- Canadian Immunization Research Network
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Protective Titres to PCV13 Serotypes Post-immunization With PCV13+PPV23 |
40; 22 | — |
| SECONDARY Number of Participants With Protective Titres to PCV7 Serotypes at Baseline |
4; 30 | — |
| SECONDARY Baseline Pneumococcal Antibody Titres in Subjects With ALL Versus Controls |
0.19; 0.52; 0.17; 1.01; 0.19; 0.54 | — |
| SECONDARY Immune Responses to Pertussis Toxin Following DTaP-IPV-Hib Booster Vaccination |
4.10; 30.67; 10.39 | — |
| SECONDARY Baseline Tetanus Toxoid Antibody Titers in Children With ALL Versus Controls |
0.16; 1.73 | — |
| SECONDARY Baseline Pertussis Toxin Titers in Children With ALL Versus Healthy Controls |
4.10; 10.35 | — |
| SECONDARY Baseline Varicella Titers in Children With ALL Versus Controls. |
0.33; 1.00 | — |
| SECONDARY Immune Responses to Tetanus Toxoid Following DTaP-IPV-Hib Immunization |
0.16; 4.00; 1.08 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02447718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.