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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
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
Clinical Infectious Diseases, Volume 74, No. 8, Year 2022
Notification
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Description
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. © The Author(s) 2021.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC9049256/bin/ciab629_suppl_supplementary_material.docx
Authors & Co-Authors
Díez Domingo, Javier
Unknown Affiliation
Tinoco-Fávila, Juan Carlos
Unknown Affiliation
Beytout, Jean
France, Clermont-ferrand
Centre Hospitalier Universitaire de Clermont-ferrand
Esen, Meral
Germany, Tubingen
Universitätsklinikum Und Medizinische Fakultät Tübingen
Ghesquiere, Wayne
Canada, Vancouver
The University of British Columbia
Hwang, Shinnjang
Taiwan, Taipei
Taipei Veterans General Hospital
Taiwan, Taipei
National Yang-ming University Taiwan
Liu, Chiu Shoung
Taiwan, Taichung
China Medical University Hospital
Rombo, Lars
Unknown Affiliation
Salaun, Bruno
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Berglund, Johan Sanmartin
Sweden, Karlskrona
Blekinge Tekniska Högskola
Schenkenberger, Isabelle
Germany, Berlin
Klinische Forschung Berlin Gbr
Schwarz, Tino Francis
Unknown Affiliation
Shi, Meng
United States, Philadelphia
Glaxosmithkline, Usa
Zahaf, Toufik
Belgium, Wavre
Glaxosmithkline Pharmaceuticals Sa/nv
Zerbini, Cristiano A.F.
Unknown Affiliation
Schuind, Anne E.
United States, Philadelphia
Glaxosmithkline, Usa
Statistics
Citations: 46
Authors: 16
Affiliations: 23
Identifiers
Doi:
10.1093/cid/ciab629
ISSN:
10584838
Study Design
Cohort Study