Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients: A Randomized Placebo-Controlled Trial (ZOE-HSCT)

Desmond Curran, Sean Matthews, Scott D. Rowley, Jo Anne H. Young, Adriana Bastidas, Achilles Anagnostopoulos, Ibrahim Barista, Pranatharthi Haran Chandrasekar, Michael Dickinson, Mohamed El Idrissi, Inmaculada Heras, Samuel T. Milliken, Jorge Monserrat Coll, María Belén Navarro Matilla, Lidia Oostvogels, Beata Piątkowska-Jakubas, Dimas Quiel, Waleed Sabry, Stefan Schwartz, Dominik L.D. SelleslagKeith M. Sullivan, Koen Theunissen, Zeynep Arzu Yegin, Su Peng Yeh, Francesco Zaja, Jeff Szer

Research output: Contribution to journalArticlepeer-review

28 Scopus citations

Abstract

Herpes zoster (HZ) can have a substantial impact on quality of life (QoL). The vaccine efficacy (VE) of a recombinant zoster vaccine (RZV) was 68.2% (95% confidence interval [CI], 55.6% to 77.5%) in a phase 3 study in adult autologous hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). Herein, we report the impact of RZV on patients’ QoL. Autologous HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1 to 2 months apart. QoL was measured by the Short Form Survey-36 and Euro-QoL-5 Dimension at baseline, 1 month, and 1 year postdose 2 and during suspected HZ episodes with the Zoster Brief Pain Inventory (ZBPI). The RZV impact on ZBPI burden of illness and burden of interference scores was estimated. The 2 scores were calculated from the area under the curve (days 0 to 182) of the ZBPI worst pain and ZBPI activities of daily living scores, respectively, assuming a score of 0 for patients not having a confirmed HZ episode. The ZBPI maximum worst pain score was significantly lower in the RZV than placebo group (mean: 5.8 versus 7.1, P =.011). Consequently, the VE estimates for HZ burden of illness (82.5%; 95% CI, 73.6 to 91.4) and burden of interference (82.8%; 95% CI, 73.3 to 92.3) were higher than the HZ VE estimate (ie, 68.2%). RZV showed significantly better QoL scores than placebo 1 week following rash onset among patients with confirmed HZ. In addition to reducing the risk of HZ and its complications, RZV significantly reduced the impact of HZ on patients’ QoL in those who developed breakthrough disease.

Original languageEnglish (US)
Pages (from-to)2474-2481
Number of pages8
JournalBiology of Blood and Marrow Transplantation
Volume25
Issue number12
DOIs
StatePublished - Dec 2019

Bibliographical note

Publisher Copyright:
© 2019 American Society for Transplantation and Cellular Therapy

Keywords

  • Autologous hematopoietic stem cell transplant
  • Herpes zoster
  • Quality of life
  • Recombinant zoster vaccine
  • Vaccination

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