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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 ...

  • 2021-07-20
  • Oxford University Press,2022
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:bth-22679
  • https://urn.kb.se/resolve?urn=urn:nbn:se:bth-22679URI
  • https://doi.org/10.1093/cid/ciab629DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-491865URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • Zoster-049 Study Groupopen access
  • 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.

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  • Hastie, AndrewGlaxoSmithKline (GSK), USA (author)
  • Diez-Domingo, JavierFISABIO Fdn Fomento Invest Sanitaria & Biomed Com, ESP (author)
  • Tinoco, Juan CarlosHosp Gen Durango, MEX (author)
  • Yu, Chong-JenNatl Taiwan Univ, TWN (author)
  • Andrews, CharlesDiagnost Res Grp, USA (author)
  • Beytout, JeanCHU Clermont Ferrand, FRA (author)
  • Caso, CovadongaHosp Clin San Carlos, ESP (author)
  • Cheng, Huey-ShinnLinkou Chang Gung Mem Hosp, TWN (author)
  • Cheong, Hee JinKorea Univ, KOR (author)
  • Choo, Eun JuSoonChunhyang Univ, KOR (author)
  • Curiac, DanSahlgrens Univ Hosp, SWE (author)
  • Di Paolo, EmmanuelGlaxoSmithKline (GSK), BEL (author)
  • Dionne, MarcUniv Laval, CAN (author)
  • Eckermann, TamaraPraxisgemeinschaft Heimeranpl, DEU (author)
  • Esen, MeralUniv Klinikum Tubingen, DEU (author)
  • Ferguson, MurdoColchester Res Grp, CAN (author)
  • Ghesquiere, WaynePerCuro Clin Res Ltd, CAN (author)
  • Hwang, Shinn-JangTaipei Vet Gen Hosp, TWN (author)
  • Avelino-Silva, Thiago JunqueiraUniv Sao Paulo, BRA (author)
  • Kosina, Pavel (author)
  • Liu, Chiu-ShongDept Infect Dis, CZE (author)
  • Markkula, JukkaTampere Univ, FIN (author)
  • Moeckesch, BeateSanta Casa de Misericordia Belo Horizonte, Ambulatorio Pesquisa Clin, BRA (author)
  • de Oliveira, Cláudia MurtaSanta Casa de Misericordia Belo Horizonte, Ambulatorio Pesquisa Clin, BRA (author)
  • Park, Dae WonKorea Univ, KOR (author)
  • Pauksens, KarlisAkad Sjukhuset, SWE (author)
  • Pirrotta, PaolaGlaxoSmithKline (GSK), BEL (author)
  • Plassmann, GeorgUHZ Klin Forsch, DEU (author)
  • Pretswell, CarolSynexus Lancashire Clin Res Ctr, GBR (author)
  • Rombo, LarsUppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD),Clin Res Ctr, Eskilstuna, SWE(Swepub:uu)larra728 (author)
  • Salaun, BrunoGlaxoSmithKline (GSK), BEL (author)
  • Sanmartin Berglund, Johan,ProfessorBlekinge Tekniska Högskola,Institutionen för hälsa(Swepub:bth)jbu (author)
  • Schenkenberger, IsabelleKFB Klin Forsch Berlin, GER (author)
  • Schwarz, TinoStandort Juliusspital, GER (author)
  • Shi, MengGlaxoSmithKline (GSK), USA (author)
  • Ukkonen, BenitaTampere Univ, FIN (author)
  • Zahaf, ToufikGlaxoSmithKline (GSK), BEL (author)
  • Zerbini, CristianoCEPIC, Ctr Paulista Invest Clin, BRA (author)
  • Schuind, AnneGlaxoSmithKline (GSK), USA (author)
  • Cunningham, Anthony LWestmead Inst Med Res, AUS (author)
  • Aixial, BELGlaxoSmithKline (GSK), USA (creator_code:org_t)

Related titles

  • In:Clinical Infectious Diseases: Oxford University Press74:8, s. 1459-14671058-48381537-6591

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