Skip to main content
OpenTrials
Completed

NCT Number: NCT05622682

Vaccine Immune Recovery After Leukemia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Lymphoblastic Leukemia, Pediatric Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

3 year–31 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational only: Serology and flow cytometry for ALL cohort participants

Other

Blood samples from ALL cohort participants will be tested to measure antibodies to vaccine-preventable diseases and immune recovery

Observational only: Infection rates

Other

Number of infections during the study period will be obtained and infection incidence rates calculated during the first year off-chemotherapy.

Primary outcomes

  1. Incident Infection Rate in Participants During the First Year Post-acute Lymphoblastic Leukemia Therapy

    Time frame: 1 year

    Infections include clinical and/or microbiologically confirmed infections as well as patient-reported infections during follow-up. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per patient-year. Patients will be censored at time of loss to follow-up, relapse, or death.

Secondary outcomes

  1. Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint

    Time frame: 1 year

    The seroprevalence proportions for measles antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.

  2. Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint

    Time frame: 1 year

    The seroprevalence proportions for varicella antibodies will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.

  3. Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint

    Time frame: 1 year

    The seroprevalence proportions for pneumococcal antibodies (23 serotypes) will be determined for the entire cohort and by demographics at each study follow-up time point (3, 6, and 12 months). Additionally, seroprevalence at each time point will be described for participants who had and had not completed their primary vaccine series before starting chemotherapy.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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)

Acronym: VIRAL

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 18, 2022
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.