TY - JOUR
T1 - Recombinant Zoster Vaccine Significantly Reduces the Impact on Quality of Life Caused by Herpes Zoster in Adult Autologous Hematopoietic Stem Cell Transplant Recipients
T2 - A Randomized Placebo-Controlled Trial (ZOE-HSCT)
AU - on behalf of ZOE-HSCT Study group collaborators
AU - Curran, Desmond
AU - Matthews, Sean
AU - Rowley, Scott D.
AU - Young, Jo Anne H.
AU - Bastidas, Adriana
AU - Anagnostopoulos, Achilles
AU - Barista, Ibrahim
AU - Chandrasekar, Pranatharthi Haran
AU - Dickinson, Michael
AU - El Idrissi, Mohamed
AU - Heras, Inmaculada
AU - Milliken, Samuel T.
AU - Monserrat Coll, Jorge
AU - Navarro Matilla, María Belén
AU - Oostvogels, Lidia
AU - Piątkowska-Jakubas, Beata
AU - Quiel, Dimas
AU - Sabry, Waleed
AU - Schwartz, Stefan
AU - Selleslag, Dominik L.D.
AU - Sullivan, Keith M.
AU - Theunissen, Koen
AU - Yegin, Zeynep Arzu
AU - Yeh, Su Peng
AU - Zaja, Francesco
AU - Szer, Jeff
N1 - Publisher Copyright:
© 2019 American Society for Transplantation and Cellular Therapy
PY - 2019/12
Y1 - 2019/12
N2 - 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.
AB - 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.
KW - Autologous hematopoietic stem cell transplant
KW - Herpes zoster
KW - Quality of life
KW - Recombinant zoster vaccine
KW - Vaccination
UR - http://www.scopus.com/inward/record.url?scp=85071901601&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85071901601&partnerID=8YFLogxK
U2 - 10.1016/j.bbmt.2019.07.036
DO - 10.1016/j.bbmt.2019.07.036
M3 - Article
C2 - 31394276
AN - SCOPUS:85071901601
SN - 1083-8791
VL - 25
SP - 2474
EP - 2481
JO - Biology of Blood and Marrow Transplantation
JF - Biology of Blood and Marrow Transplantation
IS - 12
ER -