CMV Immunity Monitoring in Lung Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2026-09-30

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.

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Detailed Description

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Conditions

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Lung Transplant; Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lung Transplant Recipients

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.

Group Type EXPERIMENTAL

Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)

Intervention Type DEVICE

Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).

Donor-Derived Cell-Free DNA (dd-cfDNA) Assay

Intervention Type DIAGNOSTIC_TEST

Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.

Valganciclovir

Intervention Type DRUG

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.

Interventions

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Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)

Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).

Intervention Type DEVICE

Donor-Derived Cell-Free DNA (dd-cfDNA) Assay

Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.

Intervention Type DIAGNOSTIC_TEST

Valganciclovir

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.

Intervention Type DRUG

Other Intervention Names

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Viracor inSIGHT Viracor TRAC

Eligibility Criteria

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Inclusion Criteria

1. Received a lung transplant, or multi-organ transplant involving a lung at NYU Langone Health
2. Pre-existing serological immunity to CMV (R+)
3. Able and willing to provide informed consent