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
- Authors
- Boutry, Celine; Hastie, Andrew; Diez-Domingo, Javier; Tinoco, Juan Carlos; Yu, Chong-Jen; Andrews, Charles; Beytout, Jean; Caso, Covadonga; 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; de Oliveira, Claudia Murta; Park, Dae Won; Pauksens, Karlis; Pirrotta, Paola; Plassmann, Georg; Pretswell, Carol; Rombo, Lars; Salaun, Bruno; Berglund, Johan Sanmartin; Schenkenberger, Isabelle; Schwarz, Tino; Shi, Meng; Ukkonen, Benita; Zahaf, Toufik; Zerbini, Cristiano; Schuind, Anne; Cunningham, Anthony L.
- Issue Date
- 4월-2022
- Publisher
- OXFORD UNIV PRESS INC
- Keywords
- adjuvanted recombinant zoster vaccine; long-term efficacy; immune response persistence
- Citation
- CLINICAL INFECTIOUS DISEASES, v.74, no.8, pp.1459 - 1467
- Indexed
- SCIE
SCOPUS
- Journal Title
- CLINICAL INFECTIOUS DISEASES
- Volume
- 74
- Number
- 8
- Start Page
- 1459
- End Page
- 1467
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/137207
- DOI
- 10.1093/cid/ciab629
- ISSN
- 1058-4838
- Abstract
- Efficacy against herpes zoster and immune responses to the adjuvanted recombinant zoster vaccine plateaued at high levels between 5.1 and 7.1 years (mean) post-vaccination, suggesting that its clinical benefit in older adults is sustained for at least 7 years post-vaccination. 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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