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2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis

BACKGROUND: The risk of herpes zoster (HZ) has been reported to vary by sex and ethnicity. In 2 large-scale clinical trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229), the adjuvanted recombinant zoster vaccine (RZV) demonstrated high vaccine efficacy (VE) against HZ and post-herpetic neuralgia (...

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Autores principales: Willer, David O, Wascotte, Valentine, Kim, Joon Hyung, Zahaf, Toufik, Talarico, Carla, Gorfinkel, Iris, Gervais, Pierre, Pharm, Pharm, L, Cunningham, Anthony L, Oostvogels, Lidia, Colindres, Romulo, Schuind, Anne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810060/
http://dx.doi.org/10.1093/ofid/ofz360.2456
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author Willer, David O
Wascotte, Valentine
Kim, Joon Hyung
Zahaf, Toufik
Talarico, Carla
Gorfinkel, Iris
Gervais, Pierre
Pharm, Pharm, L
Cunningham, Anthony L
Oostvogels, Lidia
Colindres, Romulo
Schuind, Anne
author_facet Willer, David O
Wascotte, Valentine
Kim, Joon Hyung
Zahaf, Toufik
Talarico, Carla
Gorfinkel, Iris
Gervais, Pierre
Pharm, Pharm, L
Cunningham, Anthony L
Oostvogels, Lidia
Colindres, Romulo
Schuind, Anne
author_sort Willer, David O
collection PubMed
description BACKGROUND: The risk of herpes zoster (HZ) has been reported to vary by sex and ethnicity. In 2 large-scale clinical trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229), the adjuvanted recombinant zoster vaccine (RZV) demonstrated high vaccine efficacy (VE) against HZ and post-herpetic neuralgia (PHN). We present a post-hoc analysis of RZV efficacy against HZ and PHN in the ZOE-50/70 population stratified by sex, geographic region and geographic ancestry/ethnicity. METHODS: The ZOE-50 and ZOE-70 studies were phase III, observer-blind, placebo-controlled trials conducted across 5 geographic regions. Adults ≥ 50 years of age (YOA; ZOE-50) and ≥ 70 YOA (ZOE-70), randomized 1:1, received 2 doses of RZV or placebo 2 months apart. Here, VE against HZ by sub-population was estimated from the ZOE-50 population (≥ 50 YOA) and the pooled ZOE-50/70 population (pooled ≥ 70 YOA), and VE against PHN by sub-population was evaluated in the pooled ≥ 70 YOA. RESULTS: VE was evaluated in 7,340 RZV and 7,413 placebo recipients ≥ 50 YOA (mean age: 62.3 [RZV], 62.2 [placebo] YOA) and 8,250 RZV and 8,346 placebo recipients in pooled ≥ 70 YOA (mean age: 75.5 [RZV, placebo] YOA). VE against HZ and PHN was similar for women and men in the ≥ 50 YOA and pooled ≥ 70 YOA (Tables 1 and 2). Point estimates for VE against HZ by geographic region ranged from 95.7% to 97.2% in ≥ 50 YOA and from 87.3% to 95.1% in pooled ≥ 70 YOA (Table 1). Point estimates for VE against PHN by geographic region ranged from 86.8% to 100% in pooled ≥ 70 YOA. VE was similar across geographic ancestry groups in pooled ≥ 70 YOA: VE point estimates against HZ ranged from 89.6% to 100% and VE against PHN ranged from 87.5% to 100% (Tables 1 and 2). VE against HZ was 88.1% and against PHN was 65.9% in Hispanic participants in pooled ≥ 70 YOA (Tables 1 and 2). CONCLUSION: Acknowledging the limitations including the post-hoc character of these analyses and the small number of participants and cases available, our data suggest that RZV is efficacious against HZ and PHN irrespective of sex, geographic region, geographic ancestry, and ethnicity. Funding: GlaxoSmithKline Biologicals SA. [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures.
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spelling pubmed-68100602019-10-28 2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis Willer, David O Wascotte, Valentine Kim, Joon Hyung Zahaf, Toufik Talarico, Carla Gorfinkel, Iris Gervais, Pierre Pharm, Pharm, L Cunningham, Anthony L Oostvogels, Lidia Colindres, Romulo Schuind, Anne Open Forum Infect Dis Abstracts BACKGROUND: The risk of herpes zoster (HZ) has been reported to vary by sex and ethnicity. In 2 large-scale clinical trials, ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229), the adjuvanted recombinant zoster vaccine (RZV) demonstrated high vaccine efficacy (VE) against HZ and post-herpetic neuralgia (PHN). We present a post-hoc analysis of RZV efficacy against HZ and PHN in the ZOE-50/70 population stratified by sex, geographic region and geographic ancestry/ethnicity. METHODS: The ZOE-50 and ZOE-70 studies were phase III, observer-blind, placebo-controlled trials conducted across 5 geographic regions. Adults ≥ 50 years of age (YOA; ZOE-50) and ≥ 70 YOA (ZOE-70), randomized 1:1, received 2 doses of RZV or placebo 2 months apart. Here, VE against HZ by sub-population was estimated from the ZOE-50 population (≥ 50 YOA) and the pooled ZOE-50/70 population (pooled ≥ 70 YOA), and VE against PHN by sub-population was evaluated in the pooled ≥ 70 YOA. RESULTS: VE was evaluated in 7,340 RZV and 7,413 placebo recipients ≥ 50 YOA (mean age: 62.3 [RZV], 62.2 [placebo] YOA) and 8,250 RZV and 8,346 placebo recipients in pooled ≥ 70 YOA (mean age: 75.5 [RZV, placebo] YOA). VE against HZ and PHN was similar for women and men in the ≥ 50 YOA and pooled ≥ 70 YOA (Tables 1 and 2). Point estimates for VE against HZ by geographic region ranged from 95.7% to 97.2% in ≥ 50 YOA and from 87.3% to 95.1% in pooled ≥ 70 YOA (Table 1). Point estimates for VE against PHN by geographic region ranged from 86.8% to 100% in pooled ≥ 70 YOA. VE was similar across geographic ancestry groups in pooled ≥ 70 YOA: VE point estimates against HZ ranged from 89.6% to 100% and VE against PHN ranged from 87.5% to 100% (Tables 1 and 2). VE against HZ was 88.1% and against PHN was 65.9% in Hispanic participants in pooled ≥ 70 YOA (Tables 1 and 2). CONCLUSION: Acknowledging the limitations including the post-hoc character of these analyses and the small number of participants and cases available, our data suggest that RZV is efficacious against HZ and PHN irrespective of sex, geographic region, geographic ancestry, and ethnicity. Funding: GlaxoSmithKline Biologicals SA. [Image: see text] [Image: see text] DISCLOSURES: All authors: No reported disclosures. Oxford University Press 2019-10-23 /pmc/articles/PMC6810060/ http://dx.doi.org/10.1093/ofid/ofz360.2456 Text en © The Author(s) 2019. 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
Willer, David O
Wascotte, Valentine
Kim, Joon Hyung
Zahaf, Toufik
Talarico, Carla
Gorfinkel, Iris
Gervais, Pierre
Pharm, Pharm, L
Cunningham, Anthony L
Oostvogels, Lidia
Colindres, Romulo
Schuind, Anne
2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis
title 2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis
title_full 2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis
title_fullStr 2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis
title_full_unstemmed 2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis
title_short 2779. Efficacy of the Adjuvanted Recombinant Zoster Vaccine According to Sex, Geographic Region, and Geographic Ancestry/Ethnicity: A Post-hoc Analysis
title_sort 2779. efficacy of the adjuvanted recombinant zoster vaccine according to sex, geographic region, and geographic ancestry/ethnicity: a post-hoc analysis
topic Abstracts
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6810060/
http://dx.doi.org/10.1093/ofid/ofz360.2456
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