doi:10.1093/cid/ciz1209engJarque, M.Crespo, E.Melilli, E.Gutiérrez, A.Moreso, F.Guirado, L.Revuelta, I.Montero, N.Torras, J.Riera, L.Meneghini, M.Taco, O.Manonelles, A.Paul, J.Seron, D.Facundo, C.Cruzado, J.M.Gil Vernet, S.Grinyó, J.M.Bestard, O.Cellular Immunity to Predict the Risk of Cytomegalovirus Infection in Kidney Transplantation: A Prospective, Interventional, Multicenter Clinical TrialART-2020-122432Background: Improving cytomegalovirus (CMV) immune-risk stratification in kidney transplantation is highly needed to establish guided preventive strategies. Methods: This prospective, interventional, multicenter clinical trial assessed the value of monitoring pretransplant CMV-specific cell-mediated immunity (CMI) using an interferon-γrelease assay to predict CMV infection in kidney transplantation. One hundred sixty donor/recipient CMV-seropositive (D+/R+) patients, stratified by their baseline CMV (immediate-early protein 1)-specific CMI risk, were randomized to receive either preemptive or 3-month antiviral prophylaxis. Also, 15-day posttransplant CMI risk stratification and CMI specific to the 65 kDa phosphoprotein (pp65) CMV antigen were investigated. Immunosuppression consisted of basiliximab, tacrolimus, mycophenolate mofetil, and corticosteroids in 80% of patients, whereas 20% received thymoglobulin induction therapy. Results: Patients at high risk for CMV based on pretransplant CMI developed significantly higher CMV infection rates than those deemed to be at low risk with both preemptive (73.3% vs 44.4%; odds ratio [OR], 3.44 [95% confidence interval {CI}, 1.30-9.08]) and prophylaxis (33.3% vs 4.1%; OR, 11.75 [95% CI, 2.31-59.71]) approaches. The predictive capacity for CMV-specific CMI was only found in basiliximab-treated patients for both preemptive and prophylaxis therapy. Fifteen-day CMI risk stratification better predicted CMV infection (81.3% vs 9.1%; OR, 43.33 [95% CI, 7.89-237.96]). Conclusions: Pretransplant CMV-specific CMI identifies D+/R+ kidney recipients at high risk of developing CMV infection if not receiving T-cell-depleting antibodies. Monitoring CMV-specific CMI soon after transplantation further defines the CMV infection prediction risk. Monitoring CMV-specific CMI may guide decision making regarding the type of CMV preventive strategy in kidney transplantation. Clinical Trials Registration: NCT02550639.2020http://zaguan.unizar.es/record/9927910.1093/cid/ciz1209http://zaguan.unizar.es/record/99279oai:zaguan.unizar.es:99279info:eu-repo/grantAgreement/EUR/ERDF/A way to build Europeinfo:eu-repo/grantAgreement/ES/ISCIII/ICI14-00242info:eu-repo/grantAgreement/ES/ISCIII/PI16-01321CLINICAL INFECTIOUS DISEASES 71, 9 (2020), 2375-2385All rights reservedhttp://www.europeana.eu/rights/rr-f/info:eu-repo/semantics/openAccess