Prospective Randomized Trial for Predicting CMV Infection According to Baseline CMV-Specific T-Cell Immunity in Kidney Transplant Patients.

M. Jarque,² E. Melilli,¹ A. Gutierez,³ F. Moreso,⁴ L. Guirado,⁵ A. Manonelles,¹ J. Cruzado,^1,2 S. Luque,² E. Crespo,² N. Montero,¹ F. Diekman,⁶ J. Grinyó,^1,2 O. Bestard.¹

¹Nephrology Dep, Bellvitge Hospital, Barcelona, Spain
²Nephrology Laboratory, IDIBELL, Barcelona, Spain
³Kidney Transplant Unit, Hospital Miguel Servet, Zaragoza, Spain
⁴Kidney Transplant Unit, Hospital Vall d'Hebrón, Barcelona, Spain
⁵Kidney Transplant Unit, Fundació
Puigvert, Barcelona, Spain
⁶Kidney Transplant Unit, Hospital Clínic, Barcelona, Spain

Meeting: 2017 American Transplant Congress

Abstract number: 27

Keywords: Cytomeglovirus, Kidney transplantation, Monitoring, T cell reactivity

Session Information

Session Name: Concurrent Session: Cutting Edge - Cytomegalovirus

Session Type: Concurrent Session

Date: Sunday, April 30, 2017

Session Time: 2:30pm-4:00pm

Presentation Time: 2:42pm-2:54pm

Location: E353C

Background: Despite the use of either anti-viral prophylaxis (PF) or preemptive (PE) therapy given based on donor/recipient IgG-serostatus, Cytomegalovirus (CMV) reactivation persists after kidney transplantation (KT), negatively impacting on allograft outcome. CMV-sp T-cell immunity (CTI) controls viral replication and its absence has been associated to higher infection risk, regardless recipient IgG-serostatus.

Methods: Multicentre prospective randomized trial, evaluating CTI against main CMV antigens (IE1, pp65) using the IFN-? ELISPOT assay (T-spot.CMV) in 160 CMV-IgG seropositive KT stratified into two groups according to their baseline IE-1-sp CTI and randomized to receive 3-mo PF or PE therapy and followed for 12-mo. All patients received basiliximab®, tacrolimus, MMF and prednisone but a subset (20%) received rATG induction. We report the results of an interim analysis of 90% of patients achieving at least 6-mo of follow-up.

Results: ITT analysis showed that incidence of CMV infection in negative CTI patients was 4/16(25%) in PE and 10/15(66.6%) in PF patients (p=0.02) and 2/47(4.2%) in PE and 23/48(47.9%) in PF within positive ones (p<0.001). CTI did not discriminate rATG-treated patients at risk of infection. Among patients on basiliximab®, negative CTI recipients receiving PE or PF therapy did not show higher risk of infection than positive CTI patients. However, when patients experiencing acute rejection and receiving rescue therapy were excluded of the analysis, negative CTI on PE therapy displayed significantly higher risk of infection (HR 4.86 95%CI 1.006-22.172 p=0.041) than positive CTI. Sensitivity, specificity, PPV and NPV of CTI predicting CMV infection was 33.3%, 89.3%, 70%, 67.6%, respectively.

Conclusions: Preliminary data strongly suggest that baseline IE-1-sp CTI using the T-spot.CMV identifies seropositive patients at high risk of CMV infection and thus, should be highly recommended as an additional baseline immune-risk stratification tool in patients awaiting for KT.

CITATION INFORMATION: Jarque M, Melilli E, Gutierez A, Moreso F, Guirado L, Manonelles A, Cruzado J, Luque S, Crespo E, Montero N, Diekman F, Grinyó J, Bestard O. Prospective Randomized Trial for Predicting CMV Infection According to Baseline CMV-Specific T-Cell Immunity in Kidney Transplant Patients. Am J Transplant. 2017;17 (suppl 3).

To cite this abstract in AMA style:

Jarque M, Melilli E, Gutierez A, Moreso F, Guirado L, Manonelles A, Cruzado J, Luque S, Crespo E, Montero N, Diekman F, Grinyó J, Bestard O. Prospective Randomized Trial for Predicting CMV Infection According to Baseline CMV-Specific T-Cell Immunity in Kidney Transplant Patients. [abstract]. Am J Transplant. 2017; 17 (suppl 3). https://atcmeetingabstracts.com/abstract/prospective-randomized-trial-for-predicting-cmv-infection-according-to-baseline-cmv-specific-t-cell-immunity-in-kidney-transplant-patients/. Accessed May 16, 2025.

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