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 : Active, not recruiting
First Posted : May 19, 2015
Last Update Posted : November 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphoblastic Leukemia||Biological: Prevnar®13 Biological: Pneumovax® 23 Biological: Pediacel®||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
Biological: Pneumovax® 23
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.
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.
- 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.
- 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.
- 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
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
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Principal Investigator:||Karina Top, MD, MS||Dalhousie University|