CMV Immunity Monitoring in Lung Transplant Recipients

Study Overview
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Brief Summary
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The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.

Official Title
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Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients

Conditions
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Lung Transplant; Complications

Intervention / Treatment
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* Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
* Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
* Drug: Valganciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health Pre-existing serological immunity to CMV (R+) Able and willing to provide informed consent Exclusion Criteria: Anti-thymocyte globulin induction immunosuppression Perioperative desensitization Pregnant or breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Transplant Recipients<br>Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded. | Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)<br>* Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).<br>* Other names: Viracor inSIGHT;Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay<br>* Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.<br>* Other names: Viracor TRAC;Drug: Valganciclovir<br>* Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV Viremia-Free Survival | Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood. | Up to Month 12 Post-Transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CMV Viremia | Number of times CMV DNA is detected in patients' blood. | Up to Month 12 Post-Transplant | 
| Incidence of CMV Viremia Requiring Treatment | Number of times treatment is necessary after CMV DNA is detected in patients' blood. | Up to Month 12 Post-Transplant | 
| Incidence of Treatment-Resistant CMV Viremia | Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood. | Up to Month 12 Post-Transplant | 
| Incidence of Bacterial Pneumonia | Measure of non-CMV post-transplant infectious complications. | Up to Month 12 Post-Transplant | 
| Incidence of Aspergillus Infection | Measure of non-CMV post-transplant infectious complications. | Up to Month 12 Post-Transplant | 
| Incidence of Varicella Zoster Reactivation | Measure of non-CMV post-transplant infectious complications. | Up to Month 12 Post-Transplant | 
| Incidence of Neutropenia |  | Up to Month 12 Post-Transplant |