Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients (QFT-CMV)

Cell-Mediated Immunity Based Primary Prophylaxis for CMV Infection in Organ Transplant Recipients: A Multi-Center Study

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

Study Overview

• Status: Completed
• Conditions: Cytomegalovirus Viraemia
• Intervention / Treatment: Device: Quantiferon-CMV assay

Detailed Description

Cytomegalovirus (CMV) disease is an important cause of morbidity in solid organ transplantation recipients and remains the most common opportunistic viral infection in these patients. Standard CMV prevention strategies include universal prophylaxis and pre-emptive therapy with viral load monitoring. However, neither of these strategies has been successful in eliminating CMV disease as seen by high rates of viremia, incidence, and CMV recurrence despite treatment. Recently, the Quantiferon-CMV assay has been shown to predict late CMV reactivation after prophylaxis and to be predictive of viral progression and the need for antiviral therapy in organ transplant recipients who develop low level CMV viremia. The purpose of the current study is to test the clinical strategy of using the Quantiferon-CMV assay in guiding the duration of primary CMV prophylaxis in solid organ transplant patients.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G3
      • University of Alberta Hospital
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital - Providence Health
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5C 2T2
      • St. Michael's Hospital
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network, Toronto General Hospital
• Spain
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult kidney, kidney-pancreas, liver transplant recipient, or heart transplant recipient
• CMV D+/R- patient or any R+ patient who received antithymocyte globulin induction therapy

Exclusion Criteria:

• Unable to comply with protocol
• Campath (Alemtuzumab) induction
• Receiving another investigational compound for CMV treatment or prophylaxis.
• Allergy to valganciclovir or ganciclovir
• Receiving an investigational compound for prevention or treatment of rejection, or participating in another interventional study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Quantiferon-CMV assay; All patients will receive a CMV-immunity test at specific time points during the study. This is a single arm design	Device: Quantiferon-CMV assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic CMV disease	Number of participants with symptomatic CMV disease (including viral syndrome and tissue invasive disease) at 1 year post-transplant.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of CMV viremia	Occurrence of CMV viremia as measured by QuantiFERON-CMV assay (> 1000 IU/mL)	1 year
positive vs. negative cell-mediated immunity assays	Incidence of positive vs. negative cell-mediated immunity assays post-transplant	1 year

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Canadian National Transplant Research Program
• Investigators: Principal Investigator: Atul Humar, MD, University Health Network, Toronto

Publications and helpful links

General Publications

• Gibson L. An Interferon-gamma Release Assay for Evaluation of Cell-mediated Immunity in Infants With Congenital Cytomegalovirus Infection. Clin Infect Dis. 2021 Aug 2;73(3):374-375. doi: 10.1093/cid/ciaa700. No abstract available.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): February 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: February 10, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: solid organ transplant; Quantiferon-CMV; CMV Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; DNA Virus Infections; Sepsis; Herpesviridae Infections; Viremia; Cytomegalovirus Infections
• Other Study ID Numbers: 15-9877

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: No