Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.

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.

The Failing Kidney Transplant Allograft. Transplant Nephrectomy: Current State-of-the-Art.

PURPOSE OF REVIEW: This review provides a critical literature overview of the risks and benefits of transplantectomy in patients with a failed allograft. Additionally, it offers a summary of related problems, primarily alloantibody sensitization in the event of nephrectomy and immunosuppression weaning. RECENT FINDINGS: Transplant nephrectomy has high morbidity and mortality rates. The morbidity of transplant nephrectomy (4.3 to 82%) is mostly due to hemorrhage or infection. Mortality rates range from 1.2 to 39%, and most are due to sepsis. Transvascular graft embolization has been described as a less invasive alternative technique for the management of symptomatic graft rejection, with minimal complications compared with transplantectomy. The number of patients with a failed allograft returning to dialysis is increasing. The role of allograft nephrectomy in the management of asymptomatic transplant failure is still controversial and up today continues to depend on the usual clinical practice of each institution. The less invasive transvascular embolization could have applicability in asymptomatic patients with the obvious lower morbidity and mortality rate.

Violencia de género: cuando el agresor es un paciente con demencia. A propósito de un caso / Gender violence: when the aggressor is a patient with dementia. About clinical case

No disponible