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| Name | Class |
|---|---|
| ViraCor Laboratories | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMV T cell Immunity Assay | Other | Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor) |
|
| Measure | Description | Time Frame |
|---|---|---|
| CMV Infection Incidence | CMV Infection as measured by CMV DNAemia or CMV disease | 12 months post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of detectable CMV T cell Immunity | Viracor T cell Immunity Assay | 12 months post-transplantation |
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Inclusion Criteria:
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:
I. Exclusion Criteria pre-transplant
II. Exclusion Criteria post-enrollment A) Removal from study due to minimal risk for CMV infection
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.
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Pediatric patients <18 years of age listed or anticipated to undergo kidney, heart, or liver transplantation.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Dulek, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University Medical Center/Lucile Packard Children's Hospital Stanford | Stanford | California | 94305 | United States | ||
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| Emory University Medical Center/Children's Hospital of Atlanta |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Northwestern University Medical Center/Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Albert Einstein College of Medicine/Children's Hospital at Montefiore | New York | New York | 10467 | United States |
| Duke University Medical Center/Duke Children's Hosptial | Durham | North Carolina | 27710 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| University of Pittsburgh Medical Center/Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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