CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

NCT ID: NCT03924219

Last Updated: 2024-10-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2025-07-31

Brief Summary

CMV infection and disease remain a significant clinical challenge for pediatric solid organ transplant (SOT) recipients. Current prevention strategies are limited to prophylaxis in which antiviral medication is administered for a period of several months or preemption in which close monitoring of CMV viral load from the peripheral blood is performed and treatment is initiated when CMV is detected. Each of these strategies has risks, costs, and limitations associated with it. Recently, assays for measurement of an individual patient's CMV immunity have been developed and are clinically available. One of these is the Viracor CMV T cell Immunity Panel. This flow cytometry based assay is performed on peripheral blood and measures cytokine release in response to CMV antigen stimulation by flow cytometry. The thresholds for this assay that confer protection against CMV infection in pediatric SOT recipients are not known. Defining CMV-specific cell mediated immune response thresholds that confer protection against CMV reactivation could inform patient specific durations of antiviral prophylaxis or pre-emptive surveillance testing. Therefore, the objective of this study is to quantify CMVresponsive T lymphocyte populations by flow cytometry (Viracor CMV T cell Immunity Panel) in pediatric heart, kidney, and liver transplant recipients within the first year of transplantation and to investigate potential threshold values that correlate with protection against CMV infection (DNAemia).

Conditions

Heart Transplant Infection; Kidney Transplant Infection; Liver Transplant Infection; CMV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pediatric Solid Organ Transplant (SOT) Recipients

Pediatric patients (\<18 years of age) undergoing or anticipated to undergo solid organ transplantation (heart, kidney, or liver) will be prospectively enrolled with serial blood collection for CMV T cell Immunity Assay performance.

CMV T cell Immunity Assay

Intervention Type: OTHER

Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor)

Interventions

CMV T cell Immunity Assay

Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. < 18 years of age at the time of pre-transplant enrollment

2. Potential subject is undergoing evaluation or is currently listed for isolated heart, kidney, or liver transplantation at a participating transplant center OR is anticipated to undergo living-donor kidney or liver transplantation

3. Anticipated to receive ≤ 200 days of antiviral chemoprophylaxis

Note: Subjects who are consented, enrolled, and undergo transplantation at <18 years of age will remain in the study and be followed post-transplant according to the study plan after they turn 18 years of age. Subjects will be re-consented to remain in the study at their first study visit after turning 18 years of age.

Exclusion Criteria

1. Prior history of any organ transplant

2. Prior history of hematopoietic cell transplant

3. Anticipated to receive more than one organ at the time of transplant

4. Anticipated to receive > 200 days of CMV antiviral chemoprophylaxis as part of the local transplant center's standard CMV prevention protocol

5. History of underlying primary (genetic) T cell immune deficiency

1. CMV seronegative children >= 12 months of age will be enrolled pre-transplant but will subsequently be excluded from the study IF they receive an organ from a CMV seronegative donor (CMV D-/R-).

2. Infants <12 months will be considered seronegative regardless of their CMV IgG status (whether or not this testing was obtained by the local transplant center) UNLESS the infant has a positive pre-transplant CMV culture (from urine) or a positive pre-transplant CMV PCR (from urine, saliva, or blood). Infants <12 months of age without evidence of prior CMV infection (as defined by these preceding criteria) will be excluded from post-transplant follow up IF they receive an organ from a CMV seronegative donor due to low risk for post-transplant CMV infection. Infants <12 months of age with evidence of prior CMV infection (as defined above) will remain in the study following transplantation.

B) Removal from study due to age

a. Subjects who are enrolled at <18 years of age but are not transplanted prior to their 18th birthday will be removed from the study and will not have further pre- or post-transplant follow up.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ViraCor Laboratories

INDUSTRY

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Daniel Dulek

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel Dulek, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Stanford University Medical Center/Lucile Packard Children's Hospital Stanford

Stanford, California, United States

Emory University Medical Center/Children's Hospital of Atlanta

Atlanta, Georgia, United States

Northwestern University Medical Center/Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Children's Mercy Hospital

Kansas City, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Albert Einstein College of Medicine/Children's Hospital at Montefiore

New York, New York, United States

Duke University Medical Center/Duke Children's Hosptial

Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center/Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

180947

Identifier Type: -

Identifier Source: org_study_id