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

被引：1

作者：

Strezova, Ana ^{[1
]}

Domingo, Javier Diez ^{[2
,3
]}

Cunningham, Anthony L. ^{[4
,5
]}

Eto, Takashi ^{[6
]}

Andrews, Charles ^{[7
]}

Arns, Clovis ^{[8
]}

Choo, Eun-Ju ^{[9
]}

Hui, David Shu Cheong ^{[10
]}

Icardi, Giancarlo ^{[11
,12
]}

Mcneil, Shelly A. ^{[13
]}

Poder, Airi ^{[14
]}

Kosina, Pavel ^{[15
,16
]}

Rombo, Lars ^{[17
]}

Schwarz, Tino F. ^{[18
]}

Tinoco, Juan Carlos ^{[19
]}

Yu, Chong-Jen ^{[20
,21
]}

Wang, Jing ^{[22
]}

Soni, Jyoti ^{[1
]}

Tsang, Manyee ^{[23
]}

Leon, Rafael ^{[1
]}

Mwakingwe-Omari, Agnes ^{[22
]}

机构：

[1] GSK, Wavre, Belgium

[2] FISABIO, Valencia, Spain

[3] Catholic Univ Valencia, Valencia, Spain

[4] Westmead Inst Med Res, Ctr Virus Res, Westmead, NSW, Australia

[5] Univ Sydney, Univ Sydney Inst Infect Dis, Fac Med & Hlth, Sydney, NSW, Australia

[6] Hakata Clin, Fukuoka, Japan

[7] IMA Clin Res San Antonio, San Antonio, TX USA

[8] Ctr Med Sao Francisco, Curitiba, Brazil

[9] Soonchunhyang Univ, Bucheon Hosp, Bucheon, South Korea

[10] Chinese Univ Hong Kong, Hong Kong, Peoples R China

[11] IRCCS San Martino Policlin Hosp, Hyg Unit, Genoa, Italy

[12] Univ Genoa, Dept Hlth Sci DISSAL, Genoa, Italy

[13] Dalhousie Univ, Canadian Ctr Vaccinol, IWK Hlth, NS Hlth, Halifax, NS, Canada

[14] Tartu Univ Hosp, Tartu, Estonia

[15] Univ Hosp, Dept Infect Dis, Hradec Kralove, Czech Republic

[16] Fac Med, Hradec Kralove, Czech Republic

[17] Uppsala Univ, Ctr Clin Res Sormland, Uppsala, Sweden

[18] Klinikum Wurzburg Mitte, Inst Lab Med & Vaccinat Ctr, Campus Juliusspital, WUrzburg, Germany

[19] Hosp Gen Durango, Durango, Mexico

[20] Natl Taiwan Univ, Coll Med, Taipei, Taiwan

[21] Natl Taiwan Univ Hosp, Taipei, Taiwan

[22] GSK, Rockville, MD USA

[23] GSK, London, England

来源：

ECLINICALMEDICINE | 2025年 / 83卷

关键词：

Recombinant zoster vaccine; Herpes zoster; Post-herpetic neuralgia; Long-term follow-up; POSTHERPETIC NEURALGIA; IMMUNIZATION PRACTICES; ADVISORY-COMMITTEE; SUBUNIT VACCINE; RECOMMENDATIONS; PATHOGENESIS; INFECTION; SAFETY; BURDEN; OLDER;

D O I：

10.1016/j.eclinm.2025.103241

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页数：14

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