CMV Immunity Monitoring in Lung Transplant Recipients

NCT05708755 | Recruiting Phase 2 FDA Device

• 1 other identifier: 22-01138
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Transplant; Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of CMV Viremia

  Up to Month 12 Post-Transplant

• Incidence of CMV Viremia Requiring Treatment

  Up to Month 12 Post-Transplant

• Incidence of Treatment-Resistant CMV Viremia

  Up to Month 12 Post-Transplant

• Incidence of Bacterial Pneumonia

  Up to Month 12 Post-Transplant

• Incidence of Aspergillus Infection

  Up to Month 12 Post-Transplant

Study Arms (1)

Lung Transplant Recipients

EXPERIMENTAL

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); Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay; Drug: Valganciclovir

Interventions

Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) DEVICE

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

Also known as: Viracor inSIGHT

Lung Transplant Recipients

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

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

Also known as: Viracor TRAC

Lung Transplant Recipients

Valganciclovir 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.

Lung Transplant Recipients

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anti-thymocyte globulin induction immunosuppression
• Perioperative desensitization
• Pregnant or breastfeeding women

Sponsors & Collaborators

• NYU Langone Health: lead
• Viracor Eurofins: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Interventions

Valganciclovir

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Luis Angel, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler Lewis

CONTACT

866-838-5864; Tyler.lewis@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 1, 2023
• Study Start: September 13, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)