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
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F25%3A10498709" target="_blank" >RIV/00179906:_____/25:10498709 - isvavai.cz</a>
Nalezeny alternativní kódy
RIV/00216208:11150/25:10498709
Výsledek na webu
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=E_zpTQiTwL" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=E_zpTQiTwL</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.eclinm.2025.103241" target="_blank" >10.1016/j.eclinm.2025.103241</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
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
Popis výsledku v původním jazyce
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.
Název v anglickém jazyce
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
Popis výsledku anglicky
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.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30303 - Infectious Diseases
Návaznosti výsledku
Projekt
—
Návaznosti
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Ostatní
Rok uplatnění
2025
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
EClinicalMedicine
ISSN
2589-5370
e-ISSN
2589-5370
Svazek periodika
83
Číslo periodika v rámci svazku
MAY
Stát vydavatele periodika
GB - Spojené království Velké Británie a Severního Irska
Počet stran výsledku
14
Strana od-do
103241
Kód UT WoS článku
001490717000002
EID výsledku v databázi Scopus
2-s2.0-105004657755