CMV Immunity Monitoring in Lung Transplant Recipients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Transplant; Complications
• Intervention / Treatment: Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP); Diagnostic test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay; Drug: Valganciclovir

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tyler Lewis; Phone Number: 866-838-5864; Email: Tyler.lewis@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Tyler Lewis; Phone Number: 866-838-5864; Email: Tyler.lewis@nyulangone.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

1. Anti-thymocyte globulin induction immunosuppression
2. Perioperative desensitization
3. Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Device: 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).; Other Names: Viracor inSIGHT; Diagnostic test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay; Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.; Other Names: Viracor TRAC; Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Viracor Eurofins
• Investigators: Principal Investigator: Luis Angel, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Guanine; Hypoxanthines; Purinones; Purines; Ganciclovir; Acyclovir; Valganciclovir
• Other Study ID Numbers: 22-01138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No