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The Adjuvanted Reco...
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Boutry, CélineAixial, BEL
(author)
The Adjuvanted Recombinant Zoster Vaccine Confers Long-Term Protection Against Herpes Zoster : Interim Results of an Extension Study of the Pivotal Phase 3 Clinical Trials ZOE-50 and ZOE-70
- Article/chapterEnglish2022
Publisher, publication year, extent ...
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2021-07-20
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Oxford University Press,2022
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electronicrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:bth-22679
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https://urn.kb.se/resolve?urn=urn:nbn:se:bth-22679URI
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https://doi.org/10.1093/cid/ciab629DOI
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-491865URI
Supplementary language notes
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Language:English
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Summary in:English
Part of subdatabase
Classification
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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Zoster-049 Study Groupopen access
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Efficacy against herpes zoster and immune responses to the adjuvanted recombinant zoster vaccine plateaued at high levels between 5.1 and 7.1 years (mean) post-vaccination, suggesting that its clinical benefit in older adults is sustained for at least 7 years post-vaccination. Background This ongoing follow-up study evaluated the persistence of efficacy and immune responses for 6 additional years in adults vaccinated with the glycoprotein E (gE)-based adjuvanted recombinant zoster vaccine (RZV) at age >= 50 years in 2 pivotal efficacy trials (ZOE-50 and ZOE-70). The present interim analysis was performed after >= 2 additional years of follow-up (between 5.1 and 7.1 years [mean] post-vaccination) and includes partial data for year (Y) 8 post-vaccination. Methods Annual assessments were performed for efficacy against herpes zoster (HZ) from Y6 post-vaccination and for anti-gE antibody concentrations and gE-specific CD4[2+] T-cell (expressing >= 2 of 4 assessed activation markers) frequencies from Y5 post-vaccination. Results Of 7413 participants enrolled for the long-term efficacy assessment, 7277 (mean age at vaccination, 67.2 years), 813, and 108 were included in the cohorts evaluating efficacy, humoral immune responses, and cell-mediated immune responses, respectively. Efficacy of RZV against HZ through this interim analysis was 84.0% (95% confidence interval [CI], 75.9-89.8) from the start of this follow-up study and 90.9% (95% CI, 88.2-93.2) from vaccination in ZOE-50/70. Annual vaccine efficacy estimates were >84% for each year since vaccination and remained stable through this interim analysis. Anti-gE antibody geometric mean concentrations and median frequencies of gE-specific CD4[2+] T cells reached a plateau at approximately 6-fold above pre-vaccination levels. Conclusions Efficacy against HZ and immune responses to RZV remained high, suggesting that the clinical benefit of RZV in older adults is sustained for at least 7 years post-vaccination.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Hastie, AndrewGlaxoSmithKline (GSK), USA
(author)
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Diez-Domingo, JavierFISABIO Fdn Fomento Invest Sanitaria & Biomed Com, ESP
(author)
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Tinoco, Juan CarlosHosp Gen Durango, MEX
(author)
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Yu, Chong-JenNatl Taiwan Univ, TWN
(author)
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Andrews, CharlesDiagnost Res Grp, USA
(author)
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Beytout, JeanCHU Clermont Ferrand, FRA
(author)
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Caso, CovadongaHosp Clin San Carlos, ESP
(author)
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Cheng, Huey-ShinnLinkou Chang Gung Mem Hosp, TWN
(author)
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Cheong, Hee JinKorea Univ, KOR
(author)
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Choo, Eun JuSoonChunhyang Univ, KOR
(author)
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Curiac, DanSahlgrens Univ Hosp, SWE
(author)
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Di Paolo, EmmanuelGlaxoSmithKline (GSK), BEL
(author)
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Dionne, MarcUniv Laval, CAN
(author)
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Eckermann, TamaraPraxisgemeinschaft Heimeranpl, DEU
(author)
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Esen, MeralUniv Klinikum Tubingen, DEU
(author)
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Ferguson, MurdoColchester Res Grp, CAN
(author)
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Ghesquiere, WaynePerCuro Clin Res Ltd, CAN
(author)
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Hwang, Shinn-JangTaipei Vet Gen Hosp, TWN
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Avelino-Silva, Thiago JunqueiraUniv Sao Paulo, BRA
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Kosina, Pavel
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Liu, Chiu-ShongDept Infect Dis, CZE
(author)
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Markkula, JukkaTampere Univ, FIN
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Moeckesch, BeateSanta Casa de Misericordia Belo Horizonte, Ambulatorio Pesquisa Clin, BRA
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de Oliveira, Cláudia MurtaSanta Casa de Misericordia Belo Horizonte, Ambulatorio Pesquisa Clin, BRA
(author)
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Park, Dae WonKorea Univ, KOR
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Pauksens, KarlisAkad Sjukhuset, SWE
(author)
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Pirrotta, PaolaGlaxoSmithKline (GSK), BEL
(author)
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Plassmann, GeorgUHZ Klin Forsch, DEU
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Pretswell, CarolSynexus Lancashire Clin Res Ctr, GBR
(author)
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Rombo, LarsUppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD),Clin Res Ctr, Eskilstuna, SWE(Swepub:uu)larra728
(author)
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Salaun, BrunoGlaxoSmithKline (GSK), BEL
(author)
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Sanmartin Berglund, Johan,ProfessorBlekinge Tekniska Högskola,Institutionen för hälsa(Swepub:bth)jbu
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Schenkenberger, IsabelleKFB Klin Forsch Berlin, GER
(author)
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Schwarz, TinoStandort Juliusspital, GER
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Shi, MengGlaxoSmithKline (GSK), USA
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Ukkonen, BenitaTampere Univ, FIN
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Zahaf, ToufikGlaxoSmithKline (GSK), BEL
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Zerbini, CristianoCEPIC, Ctr Paulista Invest Clin, BRA
(author)
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Schuind, AnneGlaxoSmithKline (GSK), USA
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Cunningham, Anthony LWestmead Inst Med Res, AUS
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Aixial, BELGlaxoSmithKline (GSK), USA
(creator_code:org_t)
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In:Clinical Infectious Diseases: Oxford University Press74:8, s. 1459-14671058-48381537-6591
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Boutry, Céline
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Hastie, Andrew
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Diez-Domingo, Ja ...
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Tinoco, Juan Car ...
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Yu, Chong-Jen
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Andrews, Charles
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Beytout, Jean
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Caso, Covadonga
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Cheng, Huey-Shin ...
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Cheong, Hee Jin
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Choo, Eun Ju
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Curiac, Dan
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Di Paolo, Emmanu ...
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Dionne, Marc
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Eckermann, Tamar ...
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Esen, Meral
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Ferguson, Murdo
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Ghesquiere, Wayn ...
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Hwang, Shinn-Jan ...
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Avelino-Silva, T ...
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Kosina, Pavel
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Liu, Chiu-Shong
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Markkula, Jukka
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Moeckesch, Beate
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de Oliveira, Clá ...
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Park, Dae Won
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Pauksens, Karlis
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Pirrotta, Paola
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Plassmann, Georg
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Pretswell, Carol
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Rombo, Lars
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Salaun, Bruno
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Sanmartin Berglu ...
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Schenkenberger, ...
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Schwarz, Tino
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Shi, Meng
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Ukkonen, Benita
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Zahaf, Toufik
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Zerbini, Cristia ...
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Schuind, Anne
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Cunningham, Anth ...
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Blekinge Institute of Technology
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Uppsala University