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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cytomegalovirus Viraemia

Intervention / Treatment
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* Device: Quantiferon-CMV assay


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Quantiferon-CMV assay<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quantiferon-CMV, solid organ transplant, CMV Disease