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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
C. Boutry, A. Hastie, J. Diez-Domingo, JC. Tinoco, CJ. Yu, C. Andrews, J. Beytout, C. Caso, HS. Cheng, HJ. Cheong, EJ. Choo, D. Curiac, E. Di Paolo, M. Dionne, T. Eckermann, M. Esen, M. Ferguson, W. Ghesquiere, SJ. Hwang, TJ. Avelino-Silva, P....
Language English Country United States
Document type Clinical Trial, Phase III, Journal Article
PubMed
34283213
DOI
10.1093/cid/ciab629
Knihovny.cz E-resources
- MeSH
- Adjuvants, Immunologic MeSH
- Herpes Zoster * prevention & control MeSH
- Middle Aged MeSH
- Humans MeSH
- Follow-Up Studies MeSH
- Aged MeSH
- Vaccines, Synthetic MeSH
- Herpes Zoster Vaccine * MeSH
- Herpesvirus 3, Human MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
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.
Aixial an Alten Company Brussels Belgium C O GSK Wavre Belgium
Akademiska sjukhuset Infektionskliniken Uppsala Sweden
Ambulatório de Pesquisa Clínica Santa Casa de Misericórdia de Belo Horizonte Belo Horizonte Brazil
Blekinge Institute of Technology Department of Health Karlstrona Sweden
Centro Paulista de Investigação Clínica CEPIC São Paulo Brazil
CHU de Québec Université Laval Québec City Canada
Clinical Research Centre Eskilstuna Sweden
Clinical Trial Center SU Sahlgrenska Universitetssjukhuset Göteborg Sweden
Colchester Research Group Truro Canada
Department of Infectious Diseases Hradec Kralove Czechia
Diagnostics Research Group San Antonio Texas USA
Espoo Vaccine Research Clinic Vaccine Research Center Tampere University Espoo Finland
Hospital General de Durango Durango Mexico
Institute of Tropical Medicine Universitätsklinikum Tübingen Tübingen Germany
KFB Klinische Forschung Berlin Berlin Germany
Korea University Ansan Hospital Ansan Republic of Korea
Korea University Guro Hospital Seoul Republic of Korea
Linkou Chang Gung Memorial Hospital Taoyuan City Taiwan
National Yang Ming University School of Medicine Taipei City Taiwan
Occupational Medicine and Family Medicine China Medical University Hospital Taichung Taiwan
Pori Vaccine Research Clinic Vaccine Research Center Tampere University Pori Finland
Praxis Dr med Beate Moeckesch Weinheim Germany
Praxisgemeinschaft Heimeranplatz München Germany
Service CIC CHU Clermont Ferrand Clermont Ferrand France
Servicio de Prevención Hospital Clínico San Carlos Madrid Spain
SoonChunhyang University Bucheon Hospital Bucheon si Republic of Korea
Synexus Lancashire Clinical Research Centre Chorley United Kingdom
Taipei Veterans General Hospital Taipei City Taiwan
The Westmead Institute for Medical Research Westmead NSW Australia
References provided by Crossref.org
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