Vaccine Immune Recovery After Leukemia

NCT05622682 | Completed Results

• 2 other identifiers: 21-01942661366
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

acute lymphoblastic leukemia; chemotherapy; antineoplastic agents; varicella vaccine; chickenpox vaccine; pneumococcal vaccines; measles vaccine

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 year

Secondary Outcomes (3)

• Proportion of Patients With Seroprevalence of Measles Antibodies at Each Study Timepoint

  1 year

• Proportion of Patients With Seroprevalence of Varicella Antibodies at Each Study Timepoint

  1 year

• Proportion of Patients With Seroprevalence of Pneumococcus Antibodies at Each Study Timepoint

  1 year

Study Arms (1)

Children, adolescents, and young adults who recently completed ALL treatment

This cohort of participants who recently completed leukemia therapy will be assessed for infection incidence during the year following treatment and give blood samples to be measured for antibodies to vaccine-preventable diseases. A small subset will also have their blood samples tested for B and T cell recovery.

Other: Observational only: Serology and flow cytometry for ALL cohort participants; Other: Observational only: Infection rates

Interventions

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.

Children, adolescents, and young adults who recently completed ALL treatment

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

Children, adolescents, and young adults who recently completed ALL treatment

Eligibility Criteria

• Age: 3 Years - 31 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children, adolescents, and young adults receiving care at a participating pediatric oncology/hematology center who recently completed or will soon complete treatment for acute lymphoblastic leukemia

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (6)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Helen DeVos Children's Hospital

Grand Rapids, Michigan, 49503, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

CHRISTUS Children's (Affiliate of Baylor College of Medicine)

San Antonio, Texas, 78207, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, peripheral blood mononuclear cells

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Flow Cytometry

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

This study has several limitations. Because research blood draws were timed with clinical laboratory draws at off-therapy visits, only patients with consistent follow-up were included in the vaccine titer data. Similarly, for infection incidence rates, only patients who consistently followed up and participated in study encounters were captured, meaning that some infections - perhaps among patients more likely to be ill - may have been missed.

Results Point of Contact

• Title: Morgan Hammershaimb
• Organization: Children's Hospital of Philadelphia

zalotm@chop.edu

267-426-9727

Study Officials

• Brian T Fisher, DO MSCE MPH

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 18, 2022
• Study Start: September 28, 2022
• Primary Completion: October 31, 2025
• Study Completion: November 30, 2025
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)