RT Journal Article
T1 Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation: A Randomized Clinical Trial.
A1 Bastidas, Adriana
A1 de la Serna, Javier
A1 El Idrissi, Mohamed
A1 Oostvogels, Lidia
A1 Quittet, Philippe
A1 López-Jiménez, Javier
A1 Vural, Filiz
A1 Pohlreich, David
A1 Zuckerman, Tsila
A1 Issa, Nicolas C
A1 Gaidano, Gianluca
A1 Lee, Je-Jung
A1 Abhyankar, Sunil
A1 Solano, Carlos
A1 Perez de Oteyza, Jaime
A1 Satlin, Michael J
A1 Schwartz, Stefan
A1 Campins, Magda
A1 Rocci, Alberto
A1 Vallejo Llamas, Carlos
A1 Lee, Dong-Gun
A1 Tan, Sen Mui
A1 Johnston, Anna M
A1 Grigg, Andrew
A1 Boeckh, Michael J
A1 Campora, Laura
A1 Lopez-Fauqued, Marta
A1 Heineman, Thomas C
A1 Stadtmauer, Edward A
A1 Sullivan, Keith M
A1 ZOE-HSCT Study Group Collaborators, 
AB Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. The primary end point was occurrence of confirmed herpes zoster cases. Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P  Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months. ClinicalTrials.gov Identifier: NCT01610414.
YR 2019
FD 2019
LK https://hdl.handle.net/10668/28445
UL https://hdl.handle.net/10668/28445
LA en
DS RISalud
RD Apr 17, 2025