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

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...

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Detalles Bibliográficos
Autores: Boutry, Céline, Hastie, Andrew, Díez Domingo, Javier, Tinoco, Juan Carlos, Yu, Chong-Jen, Andrews, Charles, Beytout, Jean, Covadonga, Caso, Cheng, Huey-Shinn, Cheong, Hee Jin, Choo, Eun Ju, Curiac, Dan, Di Paolo, Emmanuel, Dionne, Marc, Eckermann, Tamara, Esen, Meral, Ferguson, Murdo, Ghesquiere, Wayne, Hwang, Shinn Jang, Avelino Silva, Thiago Junqueira, Kosina, Pavel, Liu, Chiu Shong, Markkula, Jukka, Moeckesch, Beate, Murta de Oliveira, Cláudia, Park, Dae Won, Pauksens, Karlis, Pirrotta, Paola, Plassmann, Georg, Pretswell, Carol, Rombo, Lars, Salaun, Bruno, Sanmartin Berglund, Johan, Schenkenberger, Isabelle, Schwarz, Tino, Shi, Meng, Ukkonen, Benita, Zahaf, Toufik, Zerbini, Cristiano, Schuind, Anne, Cunningham, Anthony L.
Tipo de recurso: artículo
Fecha de publicación:2021
País:España
Institución:Universidad Católica de Valencia San Vicente Mártir
Repositorio:RIUCV. Repositorio de la Universidad Católica de Valencia San Vicente Mártir
Idioma:inglés
OAI Identifier:oai:riucv.ucv.es:20.500.12466/3273
Acceso en línea:http://hdl.handle.net/20.500.12466/3273
Access Level:acceso abierto
Palabra clave:Adjuvanted recombinant zoster vaccine
Long-term efficacy
Immune response persistence
3205.05 Enfermedades Infecciosas
2412.10 Vacunas
Descripción
Sumario: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.

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