Cellular Immunity to Predict the Risk of Cytomegalovirus Infection in Kidney Transplantation: A Prospective, Interventional, Multicenter Clinical TrialJarque, M., et al.
Clinical Infectious Diseases 2020 [record in progress]
The aim of this study was to investigate whether assessing pre-transplant Cytomegalovirus (CMV)-specific cell mediated immunity (CMI) could predict the risk of CMV infection in transplant patients
Participants were first categorized as low risk or high risk based on CMV-specific CMI, and then subsequenty randomized to two groups: the 3-month antiviral prophylaxis group or the preemptive therapy group.
160 CMV-seropositve renal transplant donors/recipients.
The primary outcome was the incidence of CMV infection. The secondary outcomes included rate of CMV infection in need of antiviral treatment, CMV disease rate and the rate of late-onset CMV infection following prophylaxis withdrawal; the influence of CMV-specific CMI based on the type of induction therapy; the effect of CMI on the pp65 CMV antigen; and the accuracy of prediction-risk of pre-transplant CMV-specific CMI after 15 days of transplantation.
This somewhat complicated multicenter study investigated the use of pre-transplant testing for CMV-specific cell mediated immunity (using Elispot) to predict risk of post-transplant CMV infection. Patients were stratified into 2 groups according to pre-transplant immunity, and then each group was randomized to pre-emptive or prophylactic CMV prevention strategy post-transplant. The authors found that pre-transplant immunity predicts risk of post-transplant CMV infection, but this prediction is affected by the use of lymphocyte depleting induction agents. Measuring CMV CMI at day 15 post-transplant appears to offer better prediction of risk. It should be noted that the minority of patients received lymphocyte depleting agents so the power to detect differences in this subgroup is very small (the confidence intervals around the odd-ratios given are wide). Also, the randomized intervention was the CMV prevention strategy, rather than the monitoring strategy that is compared in the primary outcome, meaning that this is really an observational rather than randomized study.
ClinicalTrials.gov - NCT02550639