Immune Monitoring to Predict Risk of Clinically Significant CMV Events after Solid Organ Transplantation (The Predict-CMV SOT Study)

Cytomegalovirus (CMV) remains one of the most common infections after transplant and despite medical advances, still poses significant challenges. Currently, transplant patients at risk of developing CMV infection are either given antiviral medications or are monitored by blood tests that detect CMV. However, these medications can have serious side effects and may only delay but not eliminate CMV infection. Furthermore, monitoring the blood for CMV ideally requires weekly blood draws.
We are designing a blood test, the CMV-AIM assay, as a personalized approach to monitoring the immune system against CMV after transplant. This test will not require additional blood collections as it will be done concurrently with routine blood tests, and not more frequently than once monthly. We have previously shown in kidney transplant patients that the CMV-AIM assay done early after transplant can predict those patients that later go on to develop CMV infection requiring treatment. The goal of this study is to trial and expand the CMV-AIM assay to all solid organ transplant patients, including lung, heart, liver, and kidney transplant patients and to validate this test in the clinical immunology laboratory to incorporate it into patient care.