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. Selleslag; Keith M. Sullivan; Koen Theunissen; Zeynep Arzu Yegin; Su Peng Yeh; Francesco Zaja; Jeff Szer

doi:10.1016/j.bbmt.2019.07.036

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

Medicine - Infectious Disease and International Medicine

Research output: Contribution to journal › Article › peer-review

19 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 language	English (US)
Pages (from-to)	2474-2481
Number of pages	8
Journal	Biology of Blood and Marrow Transplantation
Volume	25
Issue number	12
DOIs	https://doi.org/10.1016/j.bbmt.2019.07.036
State	Published - Dec 2019

Bibliographical note

Funding Information:
The authors would like to thank the study participants, investigators, and study teams involved in this trial, as well as Anne Schuind for her comments during review and Christophe Sauboin, Camelia Marcos, and Thomas C. Heineman for the patient-reported outcome questionnaire selection (ie, ZBPI, EQ-5D, and SF-36), which was included in the ZOE-HSCT clinical trial. Medical writing services were provided by Julia Donnelly (freelancer on behalf of GSK). Editorial assistance and publication coordination were provided by Sara Blancquaert (Modis on behalf of GSK). Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com. Financial disclosure: This work was funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study and covered all costs associated with developing and publishing this manuscript. Declaration of Competing Interest: During the conduct of the study, J.M.C. reports data monitoring board fees from the GSK group of companies. S.S. reports reimbursement for treatment and monitoring of study participants from the GSK group of companies. K.M.S. reports a grant and personal fees from the GSK group of companies and from NIAID, NIH awarded to Duke University. J.A.Y. reports reimbursement from the GSK group of companies to the University of Minnesota for participant enrollment. Outside the submitted work, A.A. reports grants from MERCK. S.D.R. reports consultant fees from Incyte, Fate Therapeutics, and Mesoblast. S.S. reports personal fees and nonfinancial support from AMGEN, Basilea Pharmaceutica, Gilead, Jazz Pharmaceuticals, MSD Sharp & Dohme, and Pfizer. K.M.S. reports personal fees from Kiadis Pharmaceutical and Roche Genentech. J.S. reports personal fees from Novartis; nonfinancial support from Pfizer, Sanofi Genzyme, and Shire; and grants, personal fees, and nonfinancial support from Alexion. F.Z. reports consultancy fees from Abbvie, Celgene, Gilead, Janssen, Novartis, Roche, and Sandoz; payment for lectures including service on speakers bureaus from Abbvie, Amgen, BMS, Celgene, Gilead, Janssen, Novartis, and Roche; payment for development of educational presentations from Novartis; and travel/accommodations/meeting expenses unrelated to activities listed (eg, consultancy) from Amgen, Celgene, Novartis, Roche, and Takeda. D.C. and M.E.I. are employees of the GSK group of companies. D.C. owns stock options, and M.E.I. owns stock from the GSK group of companies. S.M. works as a freelance consultant on behalf of the GSK group of companies. A.B. and L.O. were employees of the GSK group of companies during the conduct of the study and continue to own stock from the GSK group of companies. A.B. is an employee of Mithra Pharmaceuticals as of June 17, 2019. L.O. is an employee of CureVac AG as of March 1, 2018; continues to own stock from the GSK group of companies; and is inventor on a patent owned by the GSK group of companies and relevant to the recombinant zoster vaccine. I.B. P.H.C. M.D. I.H. S.T.M. M.B.N.M. B.P-J. D.Q. W.S. D.L.D.S. K.T. Z.A.Y. and S.-P.Y. have nothing to disclose. Authorship statement: A.B. D.C. M.E.I. S.T.M. L.O. and K.M.S. conceived and designed the study. A.A. I.B. A.B. P.H.C. M.D. S.T.M. J.M.C. M.B.N.M. B.P.-J. D.Q. S.D.R. W.S. S.S. D.L.D.S. K.M.S. J.S. K.T. Z.A.Y. S.-P.Y. J.A.H.Y. and F.Z. collected or generated study data. A.A. A.B. P.H.C. D.C. M.D. S.T.M. J.M.C. M.B.N.M. B.P.-J. D.Q. S.D.R. W.S. S.S. D.L.D.S. K.M.S. J.S. K.T. Z.A.Y. S.-P.Y. J.A.H.Y. and F.Z. performed the study. A.B. D.C. M.D. S.D.R. W.S. D.L.D.S. K.M.S. S.-P.Y. J.A.H.Y. and F.Z. contributed materials/analysis/reagent tools. A.B. D.C. M.E.I. S.M. L.O. S.D.R. S.S. K.M.S. J.S. K.T. and F.Z. were involved in the analysis or interpretation of the data. All authors contributed to the writing/reviewing of the manuscript and approved the final version for submission. All authors vouch for the completeness and accuracy of all the data and the presented analyses.

Funding Information:
Financial disclosure: This work was funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study and covered all costs associated with developing and publishing this manuscript.

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.bbmt.2019.07.036

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Curran, D., Matthews, S., Rowley, S. D., Young, J. A. H., Bastidas, A., Anagnostopoulos, A., Barista, I., Chandrasekar, P. H., Dickinson, M., El Idrissi, M., Heras, I., Milliken, S. T., Monserrat Coll, J., Navarro Matilla, M. B., Oostvogels, L., Piątkowska-Jakubas, B., Quiel, D., Sabry, W., Schwartz, S., ... Szer, J. (2019). 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). Biology of Blood and Marrow Transplantation, 25(12), 2474-2481. https://doi.org/10.1016/j.bbmt.2019.07.036

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). / Curran, Desmond; Matthews, Sean; Rowley, Scott D. et al.
In: Biology of Blood and Marrow Transplantation, Vol. 25, No. 12, 12.2019, p. 2474-2481.

Research output: Contribution to journal › Article › peer-review

Curran, D, Matthews, S, Rowley, SD, Young, JAH, 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, SP, Zaja, F & Szer, J 2019, '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)', Biology of Blood and Marrow Transplantation, vol. 25, no. 12, pp. 2474-2481. https://doi.org/10.1016/j.bbmt.2019.07.036

Curran D, Matthews S, Rowley SD, Young JAH, Bastidas A, Anagnostopoulos A et al. 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). Biology of Blood and Marrow Transplantation. 2019 Dec;25(12):2474-2481. doi: 10.1016/j.bbmt.2019.07.036

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title = "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)",

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{\textquoteright} 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{\textquoteright} QoL in those who developed breakthrough disease.",

keywords = "Autologous hematopoietic stem cell transplant, Herpes zoster, Quality of life, Recombinant zoster vaccine, Vaccination",

author = "Desmond Curran and Sean Matthews and Rowley, {Scott D.} and Young, {Jo Anne H.} and Adriana Bastidas and Achilles Anagnostopoulos and Ibrahim Barista and Chandrasekar, {Pranatharthi Haran} and Michael Dickinson and {El Idrissi}, Mohamed and Inmaculada Heras and Milliken, {Samuel T.} and {Monserrat Coll}, Jorge and {Navarro Matilla}, {Mar{\'i}a Bel{\'e}n} and Lidia Oostvogels and Beata Pi{\c a}tkowska-Jakubas and Dimas Quiel and Waleed Sabry and Stefan Schwartz and Selleslag, {Dominik L.D.} and Sullivan, {Keith M.} and Koen Theunissen and Yegin, {Zeynep Arzu} and Yeh, {Su Peng} and Francesco Zaja and Jeff Szer",

note = "Funding Information: The authors would like to thank the study participants, investigators, and study teams involved in this trial, as well as Anne Schuind for her comments during review and Christophe Sauboin, Camelia Marcos, and Thomas C. Heineman for the patient-reported outcome questionnaire selection (ie, ZBPI, EQ-5D, and SF-36), which was included in the ZOE-HSCT clinical trial. Medical writing services were provided by Julia Donnelly (freelancer on behalf of GSK). Editorial assistance and publication coordination were provided by Sara Blancquaert (Modis on behalf of GSK). Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com. Financial disclosure: This work was funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study and covered all costs associated with developing and publishing this manuscript. Declaration of Competing Interest: During the conduct of the study, J.M.C. reports data monitoring board fees from the GSK group of companies. S.S. reports reimbursement for treatment and monitoring of study participants from the GSK group of companies. K.M.S. reports a grant and personal fees from the GSK group of companies and from NIAID, NIH awarded to Duke University. J.A.Y. reports reimbursement from the GSK group of companies to the University of Minnesota for participant enrollment. Outside the submitted work, A.A. reports grants from MERCK. S.D.R. reports consultant fees from Incyte, Fate Therapeutics, and Mesoblast. S.S. reports personal fees and nonfinancial support from AMGEN, Basilea Pharmaceutica, Gilead, Jazz Pharmaceuticals, MSD Sharp & Dohme, and Pfizer. K.M.S. reports personal fees from Kiadis Pharmaceutical and Roche Genentech. J.S. reports personal fees from Novartis; nonfinancial support from Pfizer, Sanofi Genzyme, and Shire; and grants, personal fees, and nonfinancial support from Alexion. F.Z. reports consultancy fees from Abbvie, Celgene, Gilead, Janssen, Novartis, Roche, and Sandoz; payment for lectures including service on speakers bureaus from Abbvie, Amgen, BMS, Celgene, Gilead, Janssen, Novartis, and Roche; payment for development of educational presentations from Novartis; and travel/accommodations/meeting expenses unrelated to activities listed (eg, consultancy) from Amgen, Celgene, Novartis, Roche, and Takeda. D.C. and M.E.I. are employees of the GSK group of companies. D.C. owns stock options, and M.E.I. owns stock from the GSK group of companies. S.M. works as a freelance consultant on behalf of the GSK group of companies. A.B. and L.O. were employees of the GSK group of companies during the conduct of the study and continue to own stock from the GSK group of companies. A.B. is an employee of Mithra Pharmaceuticals as of June 17, 2019. L.O. is an employee of CureVac AG as of March 1, 2018; continues to own stock from the GSK group of companies; and is inventor on a patent owned by the GSK group of companies and relevant to the recombinant zoster vaccine. I.B. P.H.C. M.D. I.H. S.T.M. M.B.N.M. B.P-J. D.Q. W.S. D.L.D.S. K.T. Z.A.Y. and S.-P.Y. have nothing to disclose. Authorship statement: A.B. D.C. M.E.I. S.T.M. L.O. and K.M.S. conceived and designed the study. A.A. I.B. A.B. P.H.C. M.D. S.T.M. J.M.C. M.B.N.M. B.P.-J. D.Q. S.D.R. W.S. S.S. D.L.D.S. K.M.S. J.S. K.T. Z.A.Y. S.-P.Y. J.A.H.Y. and F.Z. collected or generated study data. A.A. A.B. P.H.C. D.C. M.D. S.T.M. J.M.C. M.B.N.M. B.P.-J. D.Q. S.D.R. W.S. S.S. D.L.D.S. K.M.S. J.S. K.T. Z.A.Y. S.-P.Y. J.A.H.Y. and F.Z. performed the study. A.B. D.C. M.D. S.D.R. W.S. D.L.D.S. K.M.S. S.-P.Y. J.A.H.Y. and F.Z. contributed materials/analysis/reagent tools. A.B. D.C. M.E.I. S.M. L.O. S.D.R. S.S. K.M.S. J.S. K.T. and F.Z. were involved in the analysis or interpretation of the data. All authors contributed to the writing/reviewing of the manuscript and approved the final version for submission. All authors vouch for the completeness and accuracy of all the data and the presented analyses. Funding Information: Financial disclosure: This work was funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study and covered all costs associated with developing and publishing this manuscript. Publisher Copyright: {\textcopyright} 2019 American Society for Transplantation and Cellular Therapy",

year = "2019",

month = dec,

doi = "10.1016/j.bbmt.2019.07.036",

language = "English (US)",

volume = "25",

pages = "2474--2481",

journal = "Biology of Blood and Marrow Transplantation",

issn = "1083-8791",

publisher = "Elsevier Inc.",

number = "12",

}

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 - 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 - Funding Information: The authors would like to thank the study participants, investigators, and study teams involved in this trial, as well as Anne Schuind for her comments during review and Christophe Sauboin, Camelia Marcos, and Thomas C. Heineman for the patient-reported outcome questionnaire selection (ie, ZBPI, EQ-5D, and SF-36), which was included in the ZOE-HSCT clinical trial. Medical writing services were provided by Julia Donnelly (freelancer on behalf of GSK). Editorial assistance and publication coordination were provided by Sara Blancquaert (Modis on behalf of GSK). Anonymized individual participant data and study documents can be requested for further research from www.clinicalstudydatarequest.com. Financial disclosure: This work was funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study and covered all costs associated with developing and publishing this manuscript. Declaration of Competing Interest: During the conduct of the study, J.M.C. reports data monitoring board fees from the GSK group of companies. S.S. reports reimbursement for treatment and monitoring of study participants from the GSK group of companies. K.M.S. reports a grant and personal fees from the GSK group of companies and from NIAID, NIH awarded to Duke University. J.A.Y. reports reimbursement from the GSK group of companies to the University of Minnesota for participant enrollment. Outside the submitted work, A.A. reports grants from MERCK. S.D.R. reports consultant fees from Incyte, Fate Therapeutics, and Mesoblast. S.S. reports personal fees and nonfinancial support from AMGEN, Basilea Pharmaceutica, Gilead, Jazz Pharmaceuticals, MSD Sharp & Dohme, and Pfizer. K.M.S. reports personal fees from Kiadis Pharmaceutical and Roche Genentech. J.S. reports personal fees from Novartis; nonfinancial support from Pfizer, Sanofi Genzyme, and Shire; and grants, personal fees, and nonfinancial support from Alexion. F.Z. reports consultancy fees from Abbvie, Celgene, Gilead, Janssen, Novartis, Roche, and Sandoz; payment for lectures including service on speakers bureaus from Abbvie, Amgen, BMS, Celgene, Gilead, Janssen, Novartis, and Roche; payment for development of educational presentations from Novartis; and travel/accommodations/meeting expenses unrelated to activities listed (eg, consultancy) from Amgen, Celgene, Novartis, Roche, and Takeda. D.C. and M.E.I. are employees of the GSK group of companies. D.C. owns stock options, and M.E.I. owns stock from the GSK group of companies. S.M. works as a freelance consultant on behalf of the GSK group of companies. A.B. and L.O. were employees of the GSK group of companies during the conduct of the study and continue to own stock from the GSK group of companies. A.B. is an employee of Mithra Pharmaceuticals as of June 17, 2019. L.O. is an employee of CureVac AG as of March 1, 2018; continues to own stock from the GSK group of companies; and is inventor on a patent owned by the GSK group of companies and relevant to the recombinant zoster vaccine. I.B. P.H.C. M.D. I.H. S.T.M. M.B.N.M. B.P-J. D.Q. W.S. D.L.D.S. K.T. Z.A.Y. and S.-P.Y. have nothing to disclose. Authorship statement: A.B. D.C. M.E.I. S.T.M. L.O. and K.M.S. conceived and designed the study. A.A. I.B. A.B. P.H.C. M.D. S.T.M. J.M.C. M.B.N.M. B.P.-J. D.Q. S.D.R. W.S. S.S. D.L.D.S. K.M.S. J.S. K.T. Z.A.Y. S.-P.Y. J.A.H.Y. and F.Z. collected or generated study data. A.A. A.B. P.H.C. D.C. M.D. S.T.M. J.M.C. M.B.N.M. B.P.-J. D.Q. S.D.R. W.S. S.S. D.L.D.S. K.M.S. J.S. K.T. Z.A.Y. S.-P.Y. J.A.H.Y. and F.Z. performed the study. A.B. D.C. M.D. S.D.R. W.S. D.L.D.S. K.M.S. S.-P.Y. J.A.H.Y. and F.Z. contributed materials/analysis/reagent tools. A.B. D.C. M.E.I. S.M. L.O. S.D.R. S.S. K.M.S. J.S. K.T. and F.Z. were involved in the analysis or interpretation of the data. All authors contributed to the writing/reviewing of the manuscript and approved the final version for submission. All authors vouch for the completeness and accuracy of all the data and the presented analyses. Funding Information: Financial disclosure: This work was funded by GlaxoSmithKline Biologicals SA. GlaxoSmithKline Biologicals SA was involved in all stages of the study and covered all costs associated with developing and publishing this manuscript. 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

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SP - 2474

EP - 2481

JO - Biology of Blood and Marrow Transplantation

JF - Biology of Blood and Marrow Transplantation

IS - 12

ER -

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)

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