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.
| Autor: | Boutry C; Aixial, an Alten Company, Brussels, Belgium, C/O GSK, Wavre, Belgium., Hastie A; GSK, Rockville, Maryland, USA., Diez-Domingo J; FISABIO Fundación para el Fomento Investigación Sanitaria y Biomédica de la Comunitat Valenciana, Valencia, Spain., Tinoco JC; Hospital General de Durango, Durango, Mexico., Yu CJ; Department of Internal Medicine, National Taiwan University College of Medicine and National Taiwan University Hospital, Taipei, Taiwan., Andrews C; Diagnostics Research Group, San Antonio, Texas, USA., Beytout J; Service CIC, CHU Clermont-Ferrand, Clermont-Ferrand, France., Caso C; Servicio de Prevención, Hospital Clínico San Carlos, Madrid, Spain., Cheng HS; Linkou Chang Gung Memorial Hospital, Taoyuan City, Taiwan., Cheong HJ; Korea University Guro Hospital, Seoul, Republic of Korea., Choo EJ; SoonChunhyang University Bucheon Hospital, Bucheon-si, Republic of Korea., Curiac D; Clinical Trial Center, SU/Sahlgrenska Universitetssjukhuset, Göteborg, Sweden., Di Paolo E; GSK, Rixensart, Belgium., Dionne M; CHU de Québec-Université Laval, Québec City, Canada., Eckermann T; Praxisgemeinschaft Heimeranplatz, München, Germany., Esen M; Institute of Tropical Medicine, Universitätsklinikum Tübingen, Tübingen, Germany., Ferguson M; Colchester Research Group, Truro, Canada., Ghesquiere W; Division of Infectious Diseases, UBC, Island Health Authority, PerCuro Clinical Research Ltd., Victoria, Canada., Hwang SJ; Taipei Veterans General Hospital, Taipei City, Taiwan.; National Yang Ming University School of Medicine, Taipei City, Taiwan., Avelino-Silva TJ; Laboratório de Investigação Médica em Envelhecimento (LIM-66), Serviço de Geriatria, Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil., Kosina P; Department of Infectious Diseases, Hradec Kralove, Czechia., Liu CS; Occupational Medicine and Family Medicine, China Medical University Hospital, Taichung, Taiwan., Markkula J; Pori Vaccine Research Clinic, Vaccine Research Center, Tampere University, Pori, Finland., Moeckesch B; Praxis Dr. med. Beate Moeckesch, Weinheim, Germany., Murta de Oliveira C; Ambulatório de Pesquisa Clínica, Santa Casa de Misericórdia de Belo Horizonte, Belo Horizonte, Brazil., Park DW; Korea University Ansan Hospital, Ansan, Republic of Korea., Pauksens K; Akademiska sjukhuset, Infektionskliniken, Uppsala, Sweden., Pirrotta P; GSK, Wavre, Belgium., Plassmann G; UHZ Klinische Forschung, Essen, Germany., Pretswell C; Synexus Lancashire Clinical Research Centre, Chorley, United Kingdom., Rombo L; Clinical Research Centre, Eskilstuna, Sweden., Salaun B; GSK, Rixensart, Belgium., Sanmartin Berglund J; Blekinge Institute of Technology, Department of Health, Karlstrona, Sweden., Schenkenberger I; KFB- Klinische Forschung Berlin, Berlin, Germany., Schwarz T; Institute of Laboratory Medicine and Vaccination Centre, Klinikum Würzburg Mitte, Standort Juliusspital, Würzburg, Germany., Shi M; GSK, Rockville, Maryland, USA., Ukkonen B; Espoo Vaccine Research Clinic, Vaccine Research Center, Tampere University, Espoo, Finland., Zahaf T; GSK, Wavre, Belgium., Zerbini C; Centro Paulista de Investigação Clínica, CEPIC, São Paulo, Brazil., Schuind A; GSK, Rockville, Maryland, USA., Cunningham AL; The Westmead Institute for Medical Research, Westmead, NSW, Australia.; University of Sydney, Sydney, NSW, Australia. |
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| Jazyk: | angličtina |
| Zdroj: | Clinical infectious diseases : an official publication of the Infectious Diseases Society of America [Clin Infect Dis] 2022 Apr 28; Vol. 74 (8), pp. 1459-1467. |
| DOI: | 10.1093/cid/ciab629 |
| Abstrakt: | 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. Clinical Trials Registration. NCT02723773. (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America.) |
| Databáze: | MEDLINE |
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