Vaccine Immune Recovery After Leukemia

Acute Lymphoblastic Leukemia, Pediatric Clinical Trial

— VIRAL  

Official 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)

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05622682
• Other study ID #: 21-019426
• Secondary ID: 61366
• Status: Enrolling by invitation
• Start date: September 28, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This observational study aims to assess recovery of the immune system and immunity to vaccine-preventable diseases in children and adolescents 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 approximately 75 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 95
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 31 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia, Pediatric
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Other:
• Observational only
Blood samples will be tested to measure antibodies to vaccine-preventable diseases and immune recovery

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois
United States	Helen DeVos Children's Hospital	Grand Rapids	Michigan
United States	Monroe Carell Jr. Children's Hospital at Vanderbilt	Nashville	Tennessee
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	CHRISTUS Children's (Affiliate of Baylor College of Medicine)	San Antonio	Texas
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incident infection rate in a cohort of subjects in the first year following completion of acute lymphoblastic leukemia therapy	Infections will include both clinical and/or microbiologically confirmed infections. All unique infections for a given subject will be captured and included in the final infection rate per person time estimate. Infections will also be reported in subsets of infections such as microbiologically confirmed or clinically defined infections. The total number of unique infections identified within the first year after completing chemotherapy will be reported as a rate per 1000 follow-up days. This rate will be reported for the entire cohort, by study site, and by demographics. This outcome will also be reported within subsets of infection type reported as a rate per 1000 follow-up days for the entire cohort, by study site and by specific demographic variables. All infection rates will be reported as a post estimate with 95 percent confidence intervals. Patients will be censored at time of lost to follow-up or death.	1 year
Secondary	Proportion of patients with seroprevalence of measles antibodies at each study timepoint	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.	1 year
Secondary	Proportion of patients with seroprevalence of varicella antibodies at each study timepoint	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.	1 year
Secondary	Proportion of patients with seroprevalence of pneumococcus antibodies at each study timepoint	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.	1 year
Secondary	B lymphocyte recovery in a subset of patients	B lymphocyte subsets will be measured for a subset of the 75 enrolled subjects. These measurements will be reported for each subject at approximately 3, 6, and 12 months. The trajectory of these measurements will be displayed graphically across the three timepoints of interest to assess relative recovery of lymphocyte quantities after completion of ALL chemotherapy.	1 year
Secondary	T lymphocyte recovery in a subset of patients	T lymphocyte subsets will be measured for a subset of the 75 enrolled subjects. These measurements will be reported for each subject at approximately 3, 6, and 12 months. The trajectory of these measurements will be displayed graphically across the three timepoints of interest to assess relative recovery of lymphocyte quantities after completion of ALL chemotherapy.	1 year