Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell... Key PointsQuestionWhat is the efficacy of 2 doses of the adjuvanted recombinant zoster vaccine in preventing herpes zoster in immunocompromised patients after autologous hematopoietic stem cell transplantation? FindingsIn this randomized clinical trial of 1846 patients who had undergone autologous hematopoietic stem cell transplantation, the incidence of herpes zoster over a median follow-up of 21 months was 30 per 1000 person-years after 2 recombinant zoster vaccine doses vs 94 per 1000 person-years after placebo. This difference was statistically significant. MeaningA 2-dose course of recombinant zoster vaccine reduced the incidence of herpes zoster in autologous stem cell transplant recipients. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation

Research JAMA | Original Investigation Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial Adriana Bastidas, MD; Javier de la Serna, MD; Mohamed El Idrissi, MSc; Lidia Oostvogels, MD; Philippe Quittet, MD; Javier López-Jiménez, MD, PhD; Filiz Vural, MD; David Pohlreich, MD; Tsila Zuckerman, MD; Nicolas C. Issa, MD; Gianluca Gaidano, MD, PhD; Je-Jung Lee, MD; Sunil Abhyankar, MD; Carlos Solano, MD, PhD; Jaime Perez de Oteyza, MD, PhD; Michael J. Satlin, MD; Stefan Schwartz, MD; Magda Campins, MD, PhD; Alberto Rocci, MD, PhD; Carlos Vallejo Llamas, MD, PhD; Dong-Gun Lee, MD, PhD; Sen Mui Tan, MD; Anna M. Johnston, MBBS; Andrew Grigg, MBBS, FRACP, MD; Michael J. Boeckh, MD, PhD; Laura Campora, MD; Marta Lopez-Fauqued, PhD; Thomas C. Heineman, MD, PhD; Edward A. Stadtmauer, MD; Keith M. Sullivan, MD; for the ZOE-HSCT Study Group Collaborators Supplemental content IMPORTANCE 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. OBJECTIVE To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. DESIGN, SETTING, AND PARTICIPANTS 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. INTERVENTIONS 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. MAIN OUTCOMES AND MEASURES The primary end point was occurrence of confirmed herpes zoster...
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Publisher
American Medical Association
Copyright
Copyright 2019 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2019.9053
Publisher site
See Article on Publisher Site

Abstract

Key PointsQuestionWhat is the efficacy of 2 doses of the adjuvanted recombinant zoster vaccine in preventing herpes zoster in immunocompromised patients after autologous hematopoietic stem cell transplantation? FindingsIn this randomized clinical trial of 1846 patients who had undergone autologous hematopoietic stem cell transplantation, the incidence of herpes zoster over a median follow-up of 21 months was 30 per 1000 person-years after 2 recombinant zoster vaccine doses vs 94 per 1000 person-years after placebo. This difference was statistically significant. MeaningA 2-dose course of recombinant zoster vaccine reduced the incidence of herpes zoster in autologous stem cell transplant recipients.

Journal

JAMAAmerican Medical Association

Published: Jul 9, 2019

References

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