N/A
Completed N=89
Vaccine Immune Recovery After Leukemia
Source: ClinicalTrials.gov NCT05622682 ↗Enrolled (actual)
89
Serious AEs
3.4%
Results posted
Jan 2026
Primary outcomePrimary: Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy — 3.60 Events per person-year
Summary
This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children, adolescents, and young adults who recently completed treatment for acute lymphoblastic leukemia (ALL). Several children's hospitals in the United States are participating in the study, which will enroll up to 100 pediatric participants. The study is intended to determine the rate of infection after leukemia treatment and to inform future studies and recommendations about whether children and adolescents who have leukemia should receive additional vaccine doses or boosters after treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy |
3.60 | — |
| SECONDARY Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint |
37; 30; 29 | — |
| SECONDARY Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint |
9; 8; 11 | — |
| SECONDARY Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint |
0; 0; 72; 0; 1; 74 | — |
Eligibility Criteria
Inclusion Criteria
- Children, adolescents, and young adults diagnosed with B or T ALL at age 12 months or older
- Completed ALL chemotherapy within the past three months or will complete ALL chemotherapy in the upcoming three months
- Three years of age or older at time of enrollment
Exclusion Criteria
- Diagnosis of infant ALL
- Evidence of disease relapse
- History of primary immunodeficiency (except related to Down Syndrome)
- History of a stem cell transplant or cellular immunotherapy
- History of prior malignancy or condition requiring chemotherapy other than for current ALL diagnosis
Data sourced from ClinicalTrials.gov (NCT05622682). 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. Informational only — not medical advice.