RT Journal Article
T1 Immunogenicity and Safety of the Adjuvanted Recombinant Zoster Vaccine in Chronically Immunosuppressed Adults Following Renal Transplant: A Phase 3, Randomized Clinical Trial.
A1 Vink, Peter
A1 Ramon Torrell, Josep Maria
A1 Sanchez Fructuoso, Ana
A1 Kim, Sung-Joo
A1 Kim, Sang-Il
A1 Zaltzman, Jeff
A1 Ortiz, Fernanda
A1 Campistol Plana, Josep Maria
A1 Fernandez Rodriguez, Ana Maria
A1 Rebollo Rodrigo, Henar
A1 Campins Marti, Magda
A1 Perez, Rafael
A1 González Roncero, Francisco Manuel
A1 Kumar, Deepali
A1 Chiang, Yang-Jen
A1 Doucette, Karen
A1 Pipeleers, Lissa
A1 Agüera Morales, Maria Luisa
A1 Rodriguez-Ferrero, Maria Luisa
A1 Secchi, Antonio
A1 McNeil, Shelly A
A1 Campora, Laura
A1 Di Paolo, Emmanuel
A1 El Idrissi, Mohamed
A1 López-Fauqued, Marta
A1 Salaun, Bruno
A1 Heineman, Thomas C
A1 Oostvogels, Lidia
A1 Z-041 Study Group, 
K1 herpes zoster vaccine
K1 immunogenicity
K1 immunosuppression
K1 renal transplant
K1 safety
AB 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. 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. 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. RZV was immunogenic in chronically immunosuppressed RT recipients. Immunogenicity persisted through 12M postvaccination. No safety concerns arose. NCT02058589.
YR 2020
FD 2020
LK http://hdl.handle.net/10668/13670
UL http://hdl.handle.net/10668/13670
LA en
DS RISalud
RD Apr 15, 2025