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NCT Number: NCT05708755

CMV Immunity Monitoring 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.

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Key information

Conditions

Lung Transplant; Complications

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Viracor inSIGHT

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.

Other names: Viracor TRAC

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.

Primary outcomes

  1. CMV Viremia-Free Survival

    Time frame: Up to Month 12 Post-Transplant

    Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.

Secondary outcomes

  1. Incidence of CMV Viremia

    Time frame: Up to Month 12 Post-Transplant

    Number of times CMV DNA is detected in patients' blood.

  2. Incidence of CMV Viremia Requiring Treatment

    Time frame: Up to Month 12 Post-Transplant

    Number of times treatment is necessary after CMV DNA is detected in patients' blood.

  3. Incidence of Treatment-Resistant CMV Viremia

    Time frame: Up to Month 12 Post-Transplant

    Number of times treatment for CMV Viremia does not appear effective after CMV DNA is detected in patients' blood.

  4. Incidence of Bacterial Pneumonia

    Time frame: Up to Month 12 Post-Transplant

    Measure of non-CMV post-transplant infectious complications.

  5. Incidence of Aspergillus Infection

    Time frame: Up to Month 12 Post-Transplant

    Measure of non-CMV post-transplant infectious complications.

  6. Incidence of Varicella Zoster Reactivation

    Time frame: Up to Month 12 Post-Transplant

    Measure of non-CMV post-transplant infectious complications.

  7. Incidence of Neutropenia

    Time frame: Up to Month 12 Post-Transplant

Study contacts

Contact information is provided by the study sponsor or research team.

Tyler Lewis

CONTACT

[email protected]

866-838-5864

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Viracor Eurofins

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 1, 2023
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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