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).

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

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.

Full Text

Duke Authors

Cited Authors

  • Curran, D; Matthews, S; Rowley, SD; Young, J-AH; Bastidas, A; Anagnostopoulos, A; Barista, I; Chandrasekar, PH; Dickinson, M; El Idrissi, M; Heras, I; Milliken, ST; Monserrat Coll, J; Navarro Matilla, MB; Oostvogels, L; Piątkowska-Jakubas, B; Quiel, D; Sabry, W; Schwartz, S; Selleslag, DLD; Sullivan, KM; Theunissen, K; Yegin, ZA; Yeh, S-P; Zaja, F; Szer, J; ZOE-HSCT Study group collaborators,

Published Date

  • December 2019

Published In

Volume / Issue

  • 25 / 12

Start / End Page

  • 2474 - 2481

PubMed ID

  • 31394276

Electronic International Standard Serial Number (EISSN)

  • 1523-6536

Digital Object Identifier (DOI)

  • 10.1016/j.bbmt.2019.07.036


  • eng

Conference Location

  • United States