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CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients
NCT03924219 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- OTHER CMV T cell Immunity Assay
Study Locations (12)
Pennsylvania
- Children's Hospital of Philadelphia — Philadelphia
- University of Pittsburgh Medical Center/Children's Hospital of Pittsburgh — Pittsburgh
California
- Stanford University Medical Center/Lucile Packard Children's Hospital Stanford — Stanford
Georgia
- Emory University Medical Center/Children's Hospital of Atlanta — Atlanta
Illinois
- Northwestern University Medical Center/Lurie Children's Hospital of Chicago — Chicago
Massachusetts
- Boston Children's Hospital — Boston
Missouri
- Children's Mercy Hospital — Kansas City
Nebraska
- University of Nebraska Medical Center — Omaha
New York
- Albert Einstein College of Medicine/Children's Hospital at Montefiore — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-06-03 |
| Est. Completion | 2025-07 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03924219
The ClinicalTrials.gov registry entry for NCT03924219 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with CMV appearing as the primary indexed condition, and to 1 intervention — of which CMV T cell Immunity Assay is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03924219 reports 12 study locations spanning 11 distinct geographic areas — top geographies include Pennsylvania, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03924219 about?
NCT03924219 is a clinical study titled "CMV T Cell Immunity in Pediatric Solid Organ Transplant Recipients". 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 CM...
What is the current status of trial NCT03924219?
This trial is currently active not recruiting. The enrollment target is 120 participants. The study started on 2019-06-03. Estimated completion is 2025-07.
What conditions does trial NCT03924219 study?
This clinical trial studies the following conditions: CMV, Heart Transplant Infection, Kidney Transplant Infection, Liver Transplant Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03924219?
The interventions under investigation include: CMV T cell Immunity Assay (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03924219?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03924219 being conducted?
This trial has 12 study locations across California, Georgia, Illinois, Massachusetts, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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