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Tytuł:
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The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials.
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Autorzy:
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Kim JH; GSK, Rockville, MD, USA.
Diaz-Decaro J; GSK, Rockville, MD, USA.
Jiang N; GSK, Beijing, China.
Hwang SJ; Department of Family Medicine, Taipei Veterans General Hospital, Taipei City, Taiwan.; National Yang Ming University School of Medicine, Taipei City, Taiwan.
Choo EJ; Department of Infectious Diseases, SoonChunhyang University Bucheon Hospital, Bucheon-si, Republic of Korea.
Co M; GSK, Wavre, Belgium.
Hastie A; GSK, Rockville, MD, USA.
Hui DSC; Department of Medicine and Therapeutics, The Chinese University of Hong Kong Prince of Wales Hospital, Sha Tin, Hong Kong.
Irimajiri J; Department of Dermatology, Shonan Kamakura General Hospital, Kanagawa, Japan.
Lee J; Department of Internal Medicine, Division of Infectious Diseases, Kangnam Sacred Heart Hospital, Seoul, Republic of Korea.
Leung EM; Department of Medicine and Geriatrics, Division of Geriatric Medicine and Rehabilitation, United Christian Hospital, Kwun Tong, Hong Kong.
Tang H; GSK, Shanghai, China.
Tsuru T; Medical CO.LTA PS Clinic, Fukuoka, Japan.
Watson P; GSK, Middlesex, UK.
Wu Z; GSK, Beijing, China.
Yu CJ; Department of Internal Medicine, National Taiwan University Hospital, Taipei City, Taiwan.; National Taiwan University Hospital Biomedical Park Branch Hospital, Zhubei City, Hsinchu County, Taiwan.
Yuan Y; GSK, Beijing, China.
Zahaf T; GSK, Wavre, Belgium.
Cunningham AL; The Westmead Institute for Medical Research, Westmead, Australia.; University of Sydney, Sydney, Australia.
Schuind A; GSK, Rockville, MD, USA.
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Źródło:
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Human vaccines & immunotherapeutics [Hum Vaccin Immunother] 2021 Jul 03; Vol. 17 (7), pp. 2050-2057. Date of Electronic Publication: 2021 Feb 19.
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Typ publikacji:
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Clinical Study; Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 2015- : Philadelphia, PA : Taylor & Francis
Original Publication: Austin, Tex. : Landes Bioscience
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MeSH Terms:
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Herpes Zoster*/prevention & control
Herpes Zoster Vaccine*/adverse effects
Neuralgia, Postherpetic*/prevention & control
Adult ; Cohort Studies ; Herpesvirus 3, Human ; Humans ; Middle Aged ; Randomized Controlled Trials as Topic
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References:
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Contributed Indexing:
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Keywords: Adjuvanted recombinant zoster vaccine; Asian population; efficacy; herpes zoster; postherpetic neuralgia; safety
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Molecular Sequence:
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ClinicalTrials.gov NCT01165177; NCT01165229
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Substance Nomenclature:
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0 (Herpes Zoster Vaccine)
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Entry Date(s):
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Date Created: 20210219 Date Completed: 20210705 Latest Revision: 20220531
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Update Code:
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20240105
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PubMed Central ID:
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PMC8189096
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DOI:
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10.1080/21645515.2020.1859321
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PMID:
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33606577
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In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA). This post-hoc analysis assessed the VE against HZ and postherpetic neuralgia (PHN), in participants from Asian study sites enrolled in ZOE-50/70. Reactogenicity and safety were also assessed. Participants ≥50 YOA were randomized 1:1 to receive 2 doses of either RZV or placebo, 2 months apart. VE was evaluated for a median follow-up of 4 years post-vaccination overall and by age in the ZOE-50 Asian population ≥50 YOA and in the pooled ZOE-50/70 Asian population ≥70 YOA. Of the 2,729 participants included in the ZOE-50 Asian population ≥50 YOA, 3 RZV and 66 placebo recipients reported a confirmed HZ episode. Overall VE was 95.6% (95% confidence interval [CI]: 86.4-99.1) against HZ and 100% (95% CI: 35.44-100) against PHN. In the pooled ZOE-50/70 Asian population ≥70 YOA, 4 RZV and 75 placebo recipients out of the 2,723 participants reported a confirmed HZ episode. Overall VE was 94.7% (95% CI: 85.9-98.6) against HZ and 89.8% (95% CI: 28.39-99.77) against PHN. Pain and myalgia were the most frequent solicited local and general adverse events, respectively, in both populations. No safety concern was identified during the study periods. RZV is highly efficacious against HZ and PHN and has an acceptable safety profile in Asian populations ≥50 YOA, similar to what was observed in the general ZOE-50/70 populations. Trademark statement : Shingrix is a trademark owned by or licensed to the GSK group of companies.
