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).
Study Type
OBSERVATIONAL
Enrollment
120
Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor)
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
...and 2 more locations
CMV Infection Incidence
CMV Infection as measured by CMV DNAemia or CMV disease
Time frame: 12 months post-transplantation
Frequency of detectable CMV T cell Immunity
Viracor T cell Immunity Assay
Time frame: 12 months post-transplantation
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