NCT05622682

Vaccine Immune Recovery After Leukemia

A Prospective Cohort Study to Define Infectious Burden, the Seroprevalence of Vaccine Preventable Pathogens and Immune Recovery in the First Year Following Completion of Therapy in Patients With Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 89 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 3 Years – 31 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia, Pediatric

Interventions

Type	Name	Description
OTHER	Observational only: Serology and flow cytometry for ALL cohort participants	Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery
OTHER	Observational only: Infection rates	Number of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy.

Timeline

• Start date: 2022-09-28
• Primary completion: 2025-10-31
• Completion: 2025-11-30
• First posted: 2022-11-18
• Last updated: 2026-01-26
• Results posted: 2026-01-26

Locations

6 sites across 1 country: United States