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The Adjuvanted Reco...
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
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- Boutry, Céline (author)
- Aixial, BEL
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- Hastie, Andrew (author)
- GlaxoSmithKline (GSK), USA
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- Diez-Domingo, Javier (author)
- FISABIO Fdn Fomento Invest Sanitaria & Biomed Com, ESP
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- Tinoco, Juan Carlos (author)
- Hosp Gen Durango, MEX
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- Yu, Chong-Jen (author)
- Natl Taiwan Univ, TWN
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- Andrews, Charles (author)
- Diagnost Res Grp, USA
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- Beytout, Jean (author)
- CHU Clermont Ferrand, FRA
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- Caso, Covadonga (author)
- Hosp Clin San Carlos, ESP
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- Cheng, Huey-Shinn (author)
- Linkou Chang Gung Mem Hosp, TWN
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- Cheong, Hee Jin (author)
- Korea Univ, KOR
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- Choo, Eun Ju (author)
- SoonChunhyang Univ, KOR
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- Curiac, Dan (author)
- Sahlgrens Univ Hosp, SWE
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- Di Paolo, Emmanuel (author)
- GlaxoSmithKline (GSK), BEL
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- Dionne, Marc (author)
- Univ Laval, CAN
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- Eckermann, Tamara (author)
- Praxisgemeinschaft Heimeranpl, DEU
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- Esen, Meral (author)
- Univ Klinikum Tubingen, DEU
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- Ferguson, Murdo (author)
- Colchester Res Grp, CAN
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- Ghesquiere, Wayne (author)
- PerCuro Clin Res Ltd, CAN
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- Hwang, Shinn-Jang (author)
- Taipei Vet Gen Hosp, TWN
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- Avelino-Silva, Thiago Junqueira (author)
- Univ Sao Paulo, BRA
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Kosina, Pavel (author)
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- Liu, Chiu-Shong (author)
- Dept Infect Dis, CZE
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- Markkula, Jukka (author)
- Tampere Univ, FIN
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- Moeckesch, Beate (author)
- Santa Casa de Misericordia Belo Horizonte, Ambulatorio Pesquisa Clin, BRA
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- de Oliveira, Cláudia Murta (author)
- Santa Casa de Misericordia Belo Horizonte, Ambulatorio Pesquisa Clin, BRA
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- Park, Dae Won (author)
- Korea Univ, KOR
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- Pauksens, Karlis (author)
- Akad Sjukhuset, SWE
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- Pirrotta, Paola (author)
- GlaxoSmithKline (GSK), BEL
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- Plassmann, Georg (author)
- UHZ Klin Forsch, DEU
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- Pretswell, Carol (author)
- Synexus Lancashire Clin Res Ctr, GBR
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- Rombo, Lars (author)
- Uppsala universitet,Centrum för klinisk forskning i Sörmland (CKFD),Clin Res Ctr, Eskilstuna, SWE
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- Salaun, Bruno (author)
- GlaxoSmithKline (GSK), BEL
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- Sanmartin Berglund, Johan, Professor (author)
- Blekinge Tekniska Högskola,Institutionen för hälsa
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- Schenkenberger, Isabelle (author)
- KFB Klin Forsch Berlin, GER
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- Schwarz, Tino (author)
- Standort Juliusspital, GER
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- Shi, Meng (author)
- GlaxoSmithKline (GSK), USA
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- Ukkonen, Benita (author)
- Tampere Univ, FIN
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- Zahaf, Toufik (author)
- GlaxoSmithKline (GSK), BEL
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- Zerbini, Cristiano (author)
- CEPIC, Ctr Paulista Invest Clin, BRA
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- Schuind, Anne (author)
- GlaxoSmithKline (GSK), USA
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- Cunningham, Anthony L (author)
- Westmead Inst Med Res, AUS
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(creator_code:org_t)
- 2021-07-20
- 2022
- English.
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In: Clinical Infectious Diseases. - : Oxford University Press. - 1058-4838 .- 1537-6591. ; 74:8, s. 1459-1467
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Abstract
Subject headings
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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
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Mikrobiologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Microbiology in the medical area (hsv//eng)
Keyword
- adjuvanted recombinant zoster vaccine
- long-term efficacy
- immune response persistence
- SUBUNIT VACCINE
- EPIDEMIOLOGY
- EFFICACY
Publication and Content Type
- ref (subject category)
- art (subject category)
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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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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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and Immunology in th ...
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MEDICAL AND HEAL ...
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Clinical Infecti ...
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Blekinge Institute of Technology
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Uppsala University