CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

Assessment of CMV-specific T Cell Responses by Flow Cytometry With Intracellular Cytokine Staining to Predict CMV Infection Risk in Pediatric Solid Organ Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03924219

Enrollment

161

Registered

2019-04-23

Start date

2019-06-03

Completion date

2025-07-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV, Heart Transplant Infection, Kidney Transplant Infection, Liver Transplant Infection

Keywords

cmv

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).

Interventions

OTHERCMV T cell Immunity Assay

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
CMV Infection Incidence	12 months post-transplantation	CMV Infection as measured by CMV DNAemia or CMV disease

Secondary

Measure	Time frame	Description
Frequency of detectable CMV T cell Immunity	12 months post-transplantation	Viracor T cell Immunity Assay

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORDaniel Dulek, MD

Vanderbilt University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026