Clinical Trial: Quantiferon - Cytomegalovirus (CMV) and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Quantiferon - CMV and the Prediction of CMV Infection In High Risk Solid Organ Transplant Recipients

Brief Summary: Cytomegalovirus (CMV) is a common cause of illness in patients who have undergone a transplant. Serious infections due to CMV can affect many parts of the body including the lungs, the gut, and the liver. Since transplant recipients are at risk for CMV or have evidence of infection with CMV, they are given an antiviral drug (usually ganciclovir or valganciclovir). Despite this, there are a chance that CMV infection may cause problems in the future. The purpose of this study is to assess how well patients'immune systems responds to the CMV virus, so that in the future it may be possible to predict which patients are at highest risk of CMV.

Detailed Summary:

CMV is the most common viral infection after solid organ transplantation (SOT) and is associated with significant morbidity1. Without prophylaxis, most CMV disease occurs in the first 3 months post-transplant during the period of intense of immunosuppresion.2 SOT recipients at the greatest risk are those that are seronegative recipients of organs from seropositive donors (CMV D+/R-).3, 4 Antiviral agents have proven to be useful in the prevention of CMV infection and disease in SOT recipients, including the high-risk D+/R- patients.5-9 Upon completion of prophylaxis however, CMV infection and disease occurs in about 50% and 25-30% respectively of D+/R- SOT recipients within the first year after transplant [30% rate of investigator treated CMV disease in PV16000].9 The incidence of CMV infection following prophylaxis in D+/R- lung transplant recipients may be as high as 80%.10 As CMV disease occurring after prophylaxis will continue to impact morbidity and mortality in SOT recipients, it would be desirable to be able to predict which patient will develop this complication. Currently, there are no reliable methods that are routinely available to predict the risk of CMV infection or disease in an individual patient. CMV viral load testing after prophylaxis in D+/R- patients has been shown to have poor predictive value for subsequent CMV disease.11 CMV serology (a measure of humoral immunity) was also shown to be only of marginal use in predicting the risk of late onset disease.12 Cell mediated immunity (CMI) is known to be more important than humoral immunity in controlling CMV infection. CMV infection elicits a strong virus specific CD4+ and CD8+ T-cell response. CD8+ T-cell responses to the virus often contain multiple antigen-specific reactivities including to viral pp65 or IE-1 antigens as well as pp50, glycoprotein B, and IE-2 and other antigens.13 CD4+ T cells also play a part in CMV control via promotion of priming,
Sponsor: University of Alberta

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Alberta

Dates:
Date Received: October 15, 2008
Date Started: May 2008
Date Completion:
Last Updated: April 20, 2012
Last Verified: April 2012