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

Department of Internal Medicine National Taiwan University College of Medicine and National Taiwan University Hospital Taipei Taiwan

Diagnostics Research Group San Antonio Texas USA

Division of Infectious Diseases UBC Island Health Authority PerCuro Clinical Research Ltd Victoria Canada

Espoo Vaccine Research Clinic Vaccine Research Center Tampere University Espoo Finland

FISABIO Fundación para el Fomento Investigación Sanitaria y Biomédica de la Comunitat Valenciana Valencia Spain

GSK Rixensart Belgium

GSK Rockville Maryland USA

GSK Wavre Belgium

Hospital General de Durango Durango Mexico

Institute of Laboratory Medicine and Vaccination Centre Klinikum Würzburg Mitte Standort Juliusspital Würzburg Germany

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

Laboratório de Investigação Médica em Envelhecimento Serviço de Geriatria Hospital das Clínicas HCFMUSP Faculdade de Medicina Universidade de São Paulo São Paulo Brazil

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

UHZ Klinische Forschung Essen Germany

University of Sydney Sydney NSW Australia

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ClinicalTrials.gov
NCT02723773