Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan

Abstract Background In Japan, a two-dose, recombinant herpes zoster vaccine (RZV) has been available since 2020, but vaccination coverage is low because vaccination is voluntary. This study investigated the real-world effectiveness of the RZV for preventing herpes zoster (HZ) by using clinical datab...

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Main Authors: Satoko Ohfuji, Nozomu Toyama, Kyoko Kondo, Hisao Muto, Wakaba Fukushima
Format: Article
Language:English
Published: BMC 2025-08-01
Series:BMC Infectious Diseases
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Online Access:https://doi.org/10.1186/s12879-025-11369-5
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author Satoko Ohfuji
Nozomu Toyama
Kyoko Kondo
Hisao Muto
Wakaba Fukushima
author_facet Satoko Ohfuji
Nozomu Toyama
Kyoko Kondo
Hisao Muto
Wakaba Fukushima
author_sort Satoko Ohfuji
collection DOAJ
description Abstract Background In Japan, a two-dose, recombinant herpes zoster vaccine (RZV) has been available since 2020, but vaccination coverage is low because vaccination is voluntary. This study investigated the real-world effectiveness of the RZV for preventing herpes zoster (HZ) by using clinical databases. Methods A retrospective, cohort study was conducted by using databases created at a dermatology clinic in Miyazaki Prefecture, Japan. Vaccinated patients were extracted from the Shingrix Database, and corresponding unvaccinated patients were selected from the Outpatients Database, with individuals matched by sex, age (5-year intervals), and the outpatient visit date (± 3 months from the vaccination date of the vaccinated patient). Cases of HZ as a study outcome were identified by the HZ Database until August 2024. For analysis, a Cox proportional hazard model was used to calculate the hazard ratio (HR) and 95% confidence interval (CI), and vaccine effectiveness was calculated as (1 - HR) × 100 (%). Results Between 2020 and 2023, 612 patients received the RZV, and 612 corresponding unvaccinated patients were extracted from the Outpatients Database. Of them, 2 vaccinated patients (0.3%) and 13 unvaccinated patients (2%) developed HZ from the date of the vaccination/outpatient visit until August 2024 (P < 0.01). The adjusted HR (95% CI) of vaccination for HZ infection was 0.15 (0.03–0.66), giving a vaccine effectiveness of 85%. Effectiveness was the same, regardless of age. Conclusion The RZV provides high effectiveness for preventing HZ in the clinical setting. The necessity or the timing of booster vaccination warrants further investigation.
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spelling doaj-art-a9ce2f71f5fc4d4f90a7b9801c996e4c2025-08-20T03:45:47ZengBMCBMC Infectious Diseases1471-23342025-08-012511610.1186/s12879-025-11369-5Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in JapanSatoko Ohfuji0Nozomu Toyama1Kyoko Kondo2Hisao Muto3Wakaba Fukushima4Department of Public Health, Graduate School of Medicine, Osaka Metropolitan UniversityToyama Dermatologic ClinicOMU Core Facilities Life Sciences Section, Osaka Metropolitan UniversityKusuri no Aoki Co., LtdDepartment of Public Health, Graduate School of Medicine, Osaka Metropolitan UniversityAbstract Background In Japan, a two-dose, recombinant herpes zoster vaccine (RZV) has been available since 2020, but vaccination coverage is low because vaccination is voluntary. This study investigated the real-world effectiveness of the RZV for preventing herpes zoster (HZ) by using clinical databases. Methods A retrospective, cohort study was conducted by using databases created at a dermatology clinic in Miyazaki Prefecture, Japan. Vaccinated patients were extracted from the Shingrix Database, and corresponding unvaccinated patients were selected from the Outpatients Database, with individuals matched by sex, age (5-year intervals), and the outpatient visit date (± 3 months from the vaccination date of the vaccinated patient). Cases of HZ as a study outcome were identified by the HZ Database until August 2024. For analysis, a Cox proportional hazard model was used to calculate the hazard ratio (HR) and 95% confidence interval (CI), and vaccine effectiveness was calculated as (1 - HR) × 100 (%). Results Between 2020 and 2023, 612 patients received the RZV, and 612 corresponding unvaccinated patients were extracted from the Outpatients Database. Of them, 2 vaccinated patients (0.3%) and 13 unvaccinated patients (2%) developed HZ from the date of the vaccination/outpatient visit until August 2024 (P < 0.01). The adjusted HR (95% CI) of vaccination for HZ infection was 0.15 (0.03–0.66), giving a vaccine effectiveness of 85%. Effectiveness was the same, regardless of age. Conclusion The RZV provides high effectiveness for preventing HZ in the clinical setting. The necessity or the timing of booster vaccination warrants further investigation.https://doi.org/10.1186/s12879-025-11369-5Ageing societyHerpes zosterReal-world settingRecombinant herpes zoster vaccineRetrospective cohort studyVaccine effectiveness.
spellingShingle Satoko Ohfuji
Nozomu Toyama
Kyoko Kondo
Hisao Muto
Wakaba Fukushima
Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan
BMC Infectious Diseases
Ageing society
Herpes zoster
Real-world setting
Recombinant herpes zoster vaccine
Retrospective cohort study
Vaccine effectiveness.
title Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan
title_full Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan
title_fullStr Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan
title_full_unstemmed Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan
title_short Real-world effectiveness of recombinant herpes Zoster vaccine: a retrospective, cohort study in Japan
title_sort real world effectiveness of recombinant herpes zoster vaccine a retrospective cohort study in japan
topic Ageing society
Herpes zoster
Real-world setting
Recombinant herpes zoster vaccine
Retrospective cohort study
Vaccine effectiveness.
url https://doi.org/10.1186/s12879-025-11369-5
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