See the Editorial commentary by Miller on pages 191-2.) Background. The incidence of herpes zoster is up to 9 times higher in immunosuppressed solid organ transplant recipients than in the general population. We investigated the immunogenicity and safety of an adjuvanted recombinant zoster vaccine (RZV) in renal transplant (RT) recipients ≥18 years of age receiving daily immunosuppressive therapy. Methods. In this phase 3, randomized (1:1), observer-blind, multicenter trial, RT recipients were enrolled and received 2 doses of RZV or placebo 1-2 months (M) apart 4-18M posttransplant. Anti-glycoprotein E (gE) antibody concentrations, gE-specific CD4 T-cell frequencies, and vaccine response rates were assessed at 1M post-dose 1, and 1M and 12M post-dose 2. Solicited and unsolicited adverse events (AEs) were recorded for 7 and 30 days after each dose, respectively. Solicited general symptoms and unsolicited AEs were also collected 7 days before first vaccination. Serious AEs (including biopsy-proven allograft rejections) and potential immune-mediated diseases (pIMDs) were recorded up to 12M post-dose 2. Results. Two hundred sixty-four participants (RZV: 132; placebo: 132) were enrolled between March 2014 and April 2017. gE-specific humoral and cell-mediated immune responses were higher in RZV than placebo recipients across postvaccination time points and persisted above prevaccination baseline 12M post-dose 2. Local AEs were reported more frequently by RZV than placebo recipients. Overall occurrences of renal function changes, rejections, unsolicited AEs, serious AEs, and pIMDs were similar between groups. Conclusions. RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. clinical Trials Registration. NCT02058589.

Introducción: La medida de las tasas de infección nosocomial constituye un indicador de calidad asistencial, permitiendo adoptar medidas de prevención y control. Se ha desarrollado un plan de vigilancia de infección nosocomial en los hospitales, demostrando ser un método eficaz para disminuir su incidencia.Objetivo: Conocer los indicadores y características de la infección nosocomial en general y de la infección del sitio quirúrgico en particular en un servicio de Urología de forma global y por procedimientos.Material y métodos: Estudio prospectivo mediante el sistema de vigilancia epidemiológica entre 2002-2005 en 4.618 pacientes ingresados al menos 24 horas, practicándose un total de 3.096 intervenciones.Resultados: Se observó una tasa global de infección nosocomial del 6,10%, de infección urinaria del 3,42% y de infección del sitio quirúrgico del 2,81%. De esta última por procedimientos, la cistectomía se sitúa en el 22,8%, seguido de la cirugía del riñón y uréter (6,6%) y de la cirugía abierta de próstata (4,36%).Los gérmenes más frecuentemente aislados en la infección del sitio quirúrgico son Escherichia Coli (43,6%) y Pseudomonas aeruginosa (15%). En la infección urinaria los gérmenes más frecuentes son Escherichia Coli (43,6%) y Pseudomonas aeruginosa (15%) Conclusión: Las tasas de infección nosocomial son inferiores a los valores estandares publicados. La mayor tasa de infección del sitio quirúrgico se presenta en las cirugías más complejas técnicamente, siendo Escherichia Coli, el agente etiológico más frecuente. La vigilancia de la infección del sitio quirúrgico y factores relacionados permiten incorporar elementos de mejora en la práctica clínico-quirúrgica, aportando un indicador de referencia en análisis posteriores.Palabras clave: Control de infección. Infección de herida quirúrgica. Infección del tracto urinario. ABSTRACT NOSOCOMIAL INFECTION AND INFECTION OF THE SURGICAL SITE IN A THIRD LEVEL HOSPITAL (2002-2005)Introduction: Nosocomial infection rates constitute an indicator of welfare quality, permitting to adopt measures of prevention and control. It has been developed a surveillance plan of the nosocomial infection in hospitals, showing to be an efficient method to diminish its incident.Objective: To know the indicators and characteristics of the nosocomial infection and of the infection of the site surgical particularly, in a urology service in a global form and by procedures.Matherial and methods: Prospective study by means of the epidemiological surveillance system from 2002 to 2005 in 4.618 patients hospitalised at least 24 hours, with a total of 3.096 surgical.Results: The overall incidence of nosocomial infection was 6,10%, 3.42% for urinary infection and 2,81% for the infection of the chirurgical site. For procedures, the incidence of the infection of the surgical site for cistectomy was 22,8%, 6,6% for surgery of kidney and ureter and 4,36% for open surgery of prostate.Eschericia Coli (43,6%) was the most frequently isolated organism, accounting for 43,6% of the causative organisms in...

BackgroundThe efficacy of the non-live adjuvanted recombinant zoster vaccine (RZV, containing a truncated form of varicella-zoster glycoprotein E [gE] and Adjuvant System AS01B) is >90% in adults ≥50 years of age (YOA) (ZOE-50/70) and >68% in hematopoietic stem cell transplant recipients ≥18 YOA (ZOE-HSCT).1 This study (NCT02058589) evaluated immunogenicity and safety of RZV in renal transplant recipients ≥18 YOA receiving immunosuppressive therapy. Previously unreported reactogenicity and 12-month post-last dose safety and immune persistence data are presented.MethodsIn this phase III, 1:1 randomized, observer-blind, multicenter trial, patients received 2 doses of RZV or placebo. gE-specific immune responses were assessed at 1 (M2) and 12 (M13) months post-dose 2: humoral immunity by vaccine response rate (VRR) and geometric mean antibody concentration (GMC), and cell-mediated immunity (CMI) by VRR and CD4+ T-cell frequency. Solicited general and unsolicited adverse events (AEs) were collected 7 days pre-dose 1 as a within-participant control. Solicited and unsolicited AEs were also recorded for 7 and 30 days after each dose, respectively. Serious AEs (SAE) and potential immune-mediated diseases (pIMDs) were recorded up to study end (M13).ResultsHumoral and CMI in the RZV group persisted through M13 appearing higher in the RZV group vs. placebo (Table 1). The frequency of solicited local AEs and of general AEs myalgia and fever was higher in the RZV group vs. placebo and balanced between study groups for the other general AEs, pIMDs and SAEs (including allograft rejections) (Table 2, Figure 1). No concerns regarding renal function were reported. Suspected HZ cases were recorded among 2 RZV and 6 placebo recipients. In the RZV group, within-participant pre- and post-vaccination solicited general AEs were reported at similar rates for fatigue, gastrointestinal symptoms and headache, and higher rates post-vaccination for myalgia, shivering, and fever (Figure 1).ConclusionRZV was highly immunogenic, eliciting robust humoral and CMI that persisted up to 12 months in adult renal transplant recipients. No safety concerns were identified over a 1-year follow-up.Reference1. de la Serna, BMT Tandem Meeting 2018, abs LBA2. Funding: GlaxoSmithKline Biologicals SA Disclosures P. Vink, GSK group of companies: Employee and Shareholder, Salary and stock shares. S. J. Kim, GSK group of companies: Investigator, Research grant and Research support. M. Campins Marti, GSK group of companies: Consultant, Investigator, Scientific Advisor and Speaker’s Bureau, Consulting fee, Research grant and Speaker honorarium. D. Kumar, GSK group of companies: Scientific Advisor, Consulting fee. K. Doucette, GSK group of companies: Investigator, Research support. S. A. McNeil, GSK group of companies: Grant Investigator, Research grant and Research support. L. Campora, GSK group of companies: Employee and Shareholder, Salary. E. Di Paolo, GSK group of companies: Employee, Salary. M. El Idrissi, GSK group of companies: Employee, Salary. ...

The percentage of compliance with the antibiotic protocol in our Urology Department is high. The evaluation detected two problems of a different nature and solution: to adapt the timing of antibiotics is a functional, structural and organizational problem to be resolved in accordance with the Anaesthesiology Department. The number of doses of antibiotics in open prostate surgery requires knowledge and strict adherence to the guidelines by the surgeons. The efficiency of antibiotic prophylaxis requires the existence of appropriated and updated protocols for the unifications of criteria among professionals to detect new problems as well as to find solutions for its adequate compliance.

Our nosocomial infection rates are lower than the published standard values. The main infection rate of the surgical sites present in the most complex surgical techniques, whereas Escherichia Coli is the most frecuently isolated ethiological agent. The surveillance of the infection of the surgical site and related factors permit to incorporate improvements in the clinical-surgical practice which will be an indicator of reference in subsequent analysis.