RT Journal Article
T1 Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in chronically immunosuppressed adults following renal transplant: a phase iii, randomized clinical trial
A1 Vink P, 
A1 Sánchez Fructuoso, Ana Isabel
A1 Oostvogels, L.
AB BackgroundThe 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.MethodsIn 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.ResultsTwo 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.ConclusionsRZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose.
PB Oxford Academic
YR 2020
FD 2020-01-02
LK https://hdl.handle.net/20.500.14352/126390
UL https://hdl.handle.net/20.500.14352/126390
LA eng
NO Vink P, Ramon Torrell JM, Sánchez Fructuoso A, Kim SJ, Kim SI, Zaltzman J, Ortiz F, Campistol Plana JM, Fernández Rodríguez AM, Rebollo Rodrigo H, Campins Marti M, Pérez R, González Roncero FM, Kumar D, Chiang YJ, Doucette K, Pipeleers  L, Agüera Morales ML, Rodríguez-Ferrero ML, Secchi A, McNeil SA, Campora L, Di Paolo E, El Idrissi M, López-Fauqued M, Salaun B, Heineman T, Oostvogels L; Z-041 study group. Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: a Phase III, Randomized Clinical Trial. Clin Infect Dis. 2020 Jan 2;70(2):181-190
DS Docta Complutense
RD 31 mar 2026