FindMyKOL
Clinical trialNCT03924219CompletedObservational

CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients

SponsorVanderbilt University Medical CenterEnrollment161CMVHeart Transplant InfectionKidney Transplant InfectionLiver Transplant Infection
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
3 Jun 2019
Primary completion
1 Aug 2024
Completion
1 Jul 2025
Last update posted
27 Mar 2026
Registered enrollment
161
Registry id
NCT03924219

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.