Cargando…

2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients

BACKGROUND: Herpes zoster (HZ) and its complications can have a substantial impact on patients’ quality of life (QoL), particularly in immunocompromised patients. The vaccine efficacy (VE) of an adjuvanted recombinant zoster vaccine (RZV) was studied in a randomized, placebo-controlled, phase 3 stud...

Descripción completa

Detalles Bibliográficos
Autores principales: Curran, Desmond, Anagnostopoulos, Achilles, Barista, Ibrahim, Bastidas, Adriana, Chandrasekar, Pranatharthi, Dickinson, Michael, Heras, Inmaculada, Idrissi, Mohamed El, Matthews, Sean, Milliken, Samuel, Coll, Jorge Monserrat, Matilla, Maria Belen Navarro, Oostvogels, Lidia, Quiel, Dimas, Rowley, Scott, Sabry, Waleed, Selleslag, Dominik, Szer, Jeff, Theunissen, Koen, Yegin, Zeynep Arzu, Yeh, Su-Peng, Young, Jo-Anne, Zaja, Francesco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6253678/
http://dx.doi.org/10.1093/ofid/ofy210.2135
_version_ 1783373552071737344
author Curran, Desmond
Anagnostopoulos, Achilles
Barista, Ibrahim
Bastidas, Adriana
Chandrasekar, Pranatharthi
Dickinson, Michael
Heras, Inmaculada
Idrissi, Mohamed El
Matthews, Sean
Milliken, Samuel
Coll, Jorge Monserrat
Matilla, Maria Belen Navarro
Oostvogels, Lidia
Quiel, Dimas
Rowley, Scott
Sabry, Waleed
Selleslag, Dominik
Szer, Jeff
Theunissen, Koen
Yegin, Zeynep Arzu
Yeh, Su-Peng
Young, Jo-Anne
Zaja, Francesco
author_facet Curran, Desmond
Anagnostopoulos, Achilles
Barista, Ibrahim
Bastidas, Adriana
Chandrasekar, Pranatharthi
Dickinson, Michael
Heras, Inmaculada
Idrissi, Mohamed El
Matthews, Sean
Milliken, Samuel
Coll, Jorge Monserrat
Matilla, Maria Belen Navarro
Oostvogels, Lidia
Quiel, Dimas
Rowley, Scott
Sabry, Waleed
Selleslag, Dominik
Szer, Jeff
Theunissen, Koen
Yegin, Zeynep Arzu
Yeh, Su-Peng
Young, Jo-Anne
Zaja, Francesco
author_sort Curran, Desmond
collection PubMed
description BACKGROUND: Herpes zoster (HZ) and its complications can have a substantial impact on patients’ quality of life (QoL), particularly in immunocompromised patients. The vaccine efficacy (VE) of an adjuvanted recombinant zoster vaccine (RZV) was studied in a randomized, placebo-controlled, phase 3 study in adult hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). The VE in preventing HZ cases was 68.2% (95% CI: 55.6%–77.5%). Herein we report the impact of the vaccine on patients’ quality of life (QoL) associated with HZ episodes. METHODS: HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1–2 months apart and followed for the occurrence of HZ. QoL parameters were measured by the Short-Form health survey (SF-36) and Euro-Quality of Life-5 Dimension (EQ-5D) at baseline, 1 month and 1 year post-dose 2, as well as during suspected HZ episodes in conjunction with the Zoster Brief Pain Inventory (ZBPI). For confirmed HZ cases, QoL scores were compared between the vaccine and placebo groups. The RZV impact in reducing the ZBPI Burden of Illness and Burden of Interference scores was estimated in patients in the modified total vaccinated cohort (mTVC). 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 who did not have a confirmed HZ episode. RESULTS: Both the ZBPI maximum Worst Pain and Average Pain scores were significantly lower in the vaccine than placebo group (Table 1), suggesting less burden in breakthrough HZ cases following RZV. Consequently, the HZ Burden of Illness and Burden of Interference VE estimates were higher than the HZ VE estimate. RZV showed statistically significantly better QoL scores than placebo one week following rash-onset among patients with confirmed HZ, i.e., SF-36 bodily pain, social functioning, role emotional, mental health and mental component scores, and the EQ-5D Utility Score. [Image: see text] CONCLUSION: In addition to reducing the risk of HZ and HZ complications, RZV significantly reduces the impact of HZ on patient’s QoL in those who develop breakthrough disease. Funding: GlaxoSmithKline Biologicals SA. DISCLOSURES: D. Curran, GlaxoSmithKline: Employee, GSK Shares and Salary. A. Bastidas, GSK: Employee, Salary. M. El Idrissi, GSK: Employee and Shareholder, Salary. S. Matthews, GSK group of companies: Consultant, Consulting fee. L. Oostvogels, GSK group of companies: Employee, Salary and stock and stock option. J. A. Young, GSK: Investigator, The University of Minnesota is reimbursed for contract costs associated with conducting clinical trials of vaccine. I receive no personal financial benefit.
format Online
Article
Text
id pubmed-6253678
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-62536782018-11-28 2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients Curran, Desmond Anagnostopoulos, Achilles Barista, Ibrahim Bastidas, Adriana Chandrasekar, Pranatharthi Dickinson, Michael Heras, Inmaculada Idrissi, Mohamed El Matthews, Sean Milliken, Samuel Coll, Jorge Monserrat Matilla, Maria Belen Navarro Oostvogels, Lidia Quiel, Dimas Rowley, Scott Sabry, Waleed Selleslag, Dominik Szer, Jeff Theunissen, Koen Yegin, Zeynep Arzu Yeh, Su-Peng Young, Jo-Anne Zaja, Francesco Open Forum Infect Dis Abstracts BACKGROUND: Herpes zoster (HZ) and its complications can have a substantial impact on patients’ quality of life (QoL), particularly in immunocompromised patients. The vaccine efficacy (VE) of an adjuvanted recombinant zoster vaccine (RZV) was studied in a randomized, placebo-controlled, phase 3 study in adult hematopoietic stem cell transplant (HSCT) recipients (NCT01610414). The VE in preventing HZ cases was 68.2% (95% CI: 55.6%–77.5%). Herein we report the impact of the vaccine on patients’ quality of life (QoL) associated with HZ episodes. METHODS: HSCT recipients were randomized 1:1 to receive 2 doses of RZV or placebo, given 1–2 months apart and followed for the occurrence of HZ. QoL parameters were measured by the Short-Form health survey (SF-36) and Euro-Quality of Life-5 Dimension (EQ-5D) at baseline, 1 month and 1 year post-dose 2, as well as during suspected HZ episodes in conjunction with the Zoster Brief Pain Inventory (ZBPI). For confirmed HZ cases, QoL scores were compared between the vaccine and placebo groups. The RZV impact in reducing the ZBPI Burden of Illness and Burden of Interference scores was estimated in patients in the modified total vaccinated cohort (mTVC). 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 who did not have a confirmed HZ episode. RESULTS: Both the ZBPI maximum Worst Pain and Average Pain scores were significantly lower in the vaccine than placebo group (Table 1), suggesting less burden in breakthrough HZ cases following RZV. Consequently, the HZ Burden of Illness and Burden of Interference VE estimates were higher than the HZ VE estimate. RZV showed statistically significantly better QoL scores than placebo one week following rash-onset among patients with confirmed HZ, i.e., SF-36 bodily pain, social functioning, role emotional, mental health and mental component scores, and the EQ-5D Utility Score. [Image: see text] CONCLUSION: In addition to reducing the risk of HZ and HZ complications, RZV significantly reduces the impact of HZ on patient’s QoL in those who develop breakthrough disease. Funding: GlaxoSmithKline Biologicals SA. DISCLOSURES: D. Curran, GlaxoSmithKline: Employee, GSK Shares and Salary. A. Bastidas, GSK: Employee, Salary. M. El Idrissi, GSK: Employee and Shareholder, Salary. S. Matthews, GSK group of companies: Consultant, Consulting fee. L. Oostvogels, GSK group of companies: Employee, Salary and stock and stock option. J. A. Young, GSK: Investigator, The University of Minnesota is reimbursed for contract costs associated with conducting clinical trials of vaccine. I receive no personal financial benefit. Oxford University Press 2018-11-26 /pmc/articles/PMC6253678/ http://dx.doi.org/10.1093/ofid/ofy210.2135 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Abstracts
Curran, Desmond
Anagnostopoulos, Achilles
Barista, Ibrahim
Bastidas, Adriana
Chandrasekar, Pranatharthi
Dickinson, Michael
Heras, Inmaculada
Idrissi, Mohamed El
Matthews, Sean
Milliken, Samuel
Coll, Jorge Monserrat
Matilla, Maria Belen Navarro
Oostvogels, Lidia
Quiel, Dimas
Rowley, Scott
Sabry, Waleed
Selleslag, Dominik
Szer, Jeff
Theunissen, Koen
Yegin, Zeynep Arzu
Yeh, Su-Peng
Young, Jo-Anne
Zaja, Francesco
2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
title 2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
title_full 2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
title_fullStr 2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
title_full_unstemmed 2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
title_short 2482. Impact of a Recombinant Zoster Vaccine on Quality of Life: Data from a Randomized, Placebo-Controlled, Phase 3 Trial in Adult Hematopoietic Stem Cell Transplant Recipients
title_sort 2482. impact of a recombinant zoster vaccine on quality of life: data from a randomized, placebo-controlled, phase 3 trial in adult hematopoietic stem cell transplant recipients
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6253678/
http://dx.doi.org/10.1093/ofid/ofy210.2135
work_keys_str_mv AT currandesmond 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT anagnostopoulosachilles 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT baristaibrahim 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT bastidasadriana 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT chandrasekarpranatharthi 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT dickinsonmichael 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT herasinmaculada 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT idrissimohamedel 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT matthewssean 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT millikensamuel 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT colljorgemonserrat 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT matillamariabelennavarro 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT oostvogelslidia 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT quieldimas 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT rowleyscott 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT sabrywaleed 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT selleslagdominik 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT szerjeff 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT theunissenkoen 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT yeginzeyneparzu 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT yehsupeng 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT youngjoanne 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT zajafrancesco 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients
AT 2482impactofarecombinantzostervaccineonqualityoflifedatafromarandomizedplacebocontrolledphase3trialinadulthematopoieticstemcelltransplantrecipients