Final analysis of the ZOE-LTFU trial to 11 years post-vaccination: efficacy of the adjuvanted recombinant zoster vaccine against herpes zoster and related complications
Background Herpes zoster (HZ) vaccines should provide durable protection against HZ and HZ-related complications. We report the final analysis of a long-term follow-up (LTFU) study (ZOE-LTFU) including 11 years of follow-up after primary vaccination with recombinant zoster vaccine (RZV). Methods ZOE...
| Autores: | , , , , , , , , , , , , , , , , , , , , |
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| Tipo de documento: | artigo |
| Estado: | Versão publicada |
| Data de publicação: | 2025 |
| País: | España |
| Recursos: | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) |
| Repositório: | r-FISABIO. Repositorio Institucional de Producción Científica |
| OAI Identifier: | oai:fisabio.fundanetsuite.com:p18952 |
| Acesso em linha: | https://fisabio.portalinvestigacion.com/publicaciones/18952 |
| Access Level: | Acceso aberto |
| Palavra-chave: | Recombinant zoster vaccine Herpes zoster Post-herpetic neuralgia Long-term follow-up |
| Resumo: | Background Herpes zoster (HZ) vaccines should provide durable protection against HZ and HZ-related complications. We report the final analysis of a long-term follow-up (LTFU) study (ZOE-LTFU) including 11 years of follow-up after primary vaccination with recombinant zoster vaccine (RZV). Methods ZOE-LTFU (NCT02723773) was an open-label, phase 3b study following participants of two phase 3 trials, ZOE-50 and ZOE-70. ZOE-LTFU started approximately 5 years post-vaccination in ZOE-50/70 and participants were followed for 6 years. The primary objective was to assess vaccine efficacy (VE) against HZ during ZOE-LTFU. Secondary objectives included VE against HZ from 1 month post-dose 2 in ZOE-50/70 until end of ZOE-LTFU, VE against post-herpetic neuralgia (PHN) and non-PHN complications, immunogenicity, and long-term safety. The VE calculation used a historical control constructed with ZOE-50/70 placebo data. Findings VE was assessed in the modified total vaccinated cohort (n = 7273 [mean age 67.3 years at first vaccination]). During ZOE-LTFU, VE was 79.8% (95% confidence interval [CI]: 73.7, 84.6) and 73.2% (95% CI: 62.9, 80.9) against HZ in participants >= 50 and >= 70 years at first vaccination, respectively, and was 87.5% (95% CI: 64.8, 96.8) against PHN and 91.7% (95% CI: 43.7, 99.8) against other HZ-related complications in participants >= 50 years. From 1 month post-dose 2 in ZOE-50/70 to the end of ZOE-LTFU, VE against HZ was 87.7% (95% CI: 84.9, 90.1) in participants >= 50 years and sustained at 82.0% (95% CI: 63.0, 92.2) in the eleventh year post-vaccination. Humoural and cell-mediated immune responses plateaued at over 5-fold and similar to 7-fold, respectively, above pre-vaccination levels in ZOE-50/70. No RZV-related serious adverse events occurred. Interpretation Efficacy of RZV against HZ and associated complications remained high through 11 years postvaccination, indicating sustained clinical benefit. |
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