Efficacy, Safety and Immunogenicity of a Novel Adjuvanted Subunit Herpes Zoster Vaccine in Japanese Aged 50 Years and 70 Years and Older

Ikematsu, Hideyuki; Yamashita, Nobuyuki; Ogawa, Masayuki; Hirano, Motonori; Kovac, Martina; Watanabe, Daisuke

doi:10.11150/kansenshogakuzasshi.92.103

Cited by 5 publications

(3 citation statements)

References 22 publications

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“…The VE of RZV was assessed in two phase III clinical trials in 16,161 individuals aged ≥ 50 years (ZOE-50) and in 14,816 individuals aged ≥ 70 years (ZOE-70) [ 31 , 32 ]. Japanese subgroup analyses in these studies revealed that RZV demonstrated a high efficacy in the Japanese population as well [ 33 ]. However, the results of the global trials were selected for this model analysis because of their larger sample sizes.…”

Section: Methodsmentioning

confidence: 99%

The Potential Public Health Impact of Herpes Zoster Vaccination of People Aged ≥ 50 Years in Japan: Results of a Markov Model Analysis

Watanabe

Mizukami

Holl

et al. 2018

Dermatol Ther (Heidelb)

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IntroductionThe aim of this study was to compare the public health impact of introducing two herpes zoster (HZ) vaccines into the vaccination programs for the Japanese population aged ≥ 50 years: a single-dose Varicella Vaccine Live (VVL) or a two-dose adjuvanted Recombinant Zoster Vaccine (RZV).MethodsA multi-cohort static Markov model was developed to follow age cohorts (50–59, 60–69, 70–79 and ≥ 80 years) over their remaining lifetime. Japan-specific data inputs for the model were obtained from Japanese data sources. Age-stratified vaccine efficacy and waning rates were based on published clinical trial data. In the base-case analysis, vaccine coverage was assumed to be 40% for both vaccines, and compliance with second-dose of the RZV vaccine was set to 95%.ResultsVaccination with RZV was projected to prevent approximately 3.3 million HZ cases, 692,000 cases of postherpetic neuralgia (PHN), and 281,000 cases of other complications, compared with the prevention of 0.8 million HZ cases, 216,000 PHN cases, and 57,000 other complications with vaccination with VVL. The number of individuals needed to vaccinate in order to prevent one HZ case ranged from 6 to 14 using RZV (depending on age and assumed second-dose compliance) and from 21 to 138 depending on age using VVL. By preventing a higher number of HZ cases and its complications, RZV vaccination led to fewer outpatient visits and hospitalizations than vaccination with VVL.ConclusionBoth vaccines had a positive public health impact compared to no vaccination, but due to its higher vaccine efficacy, RZV demonstrated a superior public health impact compared with VVL.FundingGlaxoSmithKline Biologicals SA.Electronic supplementary materialThe online version of this article (10.1007/s13555-018-0236-3) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

The Potential Public Health Impact of Herpes Zoster Vaccination of People Aged ≥ 50 Years in Japan: Results of a Markov Model Analysis

Watanabe

Mizukami

Holl

et al. 2018

Dermatol Ther (Heidelb)

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“…20,[22][23][24] The efficacy of RZV has been demonstrated in two large, global phase III trials (both of which included Japanese subjects) where vaccine efficacy of over 90% for HZ and for PHN was observed. 25,26 Recent cost-effectiveness analyses for the use of RZV in Japan have estimated that RZV could prevent a substantially greater number of HZ cases and reduce…”

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confidence: 99%

Risk of herpes zoster in the Japanese population with immunocompromising and chronic disease conditions: Results from a claims database cohort study, from 2005 to 2014

Imafuku

Dormal²,

Goto³

et al. 2020

The Journal of Dermatology

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Older adults, women and patients with immunocompromised (IC) or chronic medical conditions have a higher incidence of herpes zoster (HZ) and are at higher risk of developing HZ‐associated complications such as postherpetic neuralgia. The incidence rates of HZ in various IC and chronic conditions have been previously reported in a retrospective cohort study using claims data from Japanese adults. Here, we report further analyses from this cohort using univariate and multivariable Cox regression to estimate crude and adjusted hazard ratios (HRs) associated with different IC and chronic conditions. After adjusting for multiple covariates (age, sex and other coexisting medical conditions), the risk of HZ was higher in women (HR, 1.14 [95% CI, 1.11–1.17]), irrespective of age and increased with increasing age, being substantially higher in patients aged 65 years or older (HR, 3.28 [95% CI, 3.07–3.49]) when compared with those aged 18–29 years. The highest HRs were observed for the following specific IC conditions; hematopoietic stem cell transplant recipients (HR, 9.85 [95% CI, 6.80–14.28]), hematological malignancy (HR, 3.22 [95% CI, 2.54–4.09]), systemic lupus erythematosus (HR, 2.46 [95% CI, 1.45–4.15]) and inflammatory bowel disease (HR, 1.59 [95% CI, 1.14–2.21]). For most other IC and chronic medical conditions, a higher risk was also apparent though of a smaller magnitude (HRs ranging from 1.2 to <1.5). These results corroborate our previous findings and demonstrate an increased risk of HZ associated with different IC and chronic conditions.

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“…Other recently published post-hoc analyses of data from the ZOE-50/70 trials demonstrated no impact of geographic ancestry/ethnicity, region, sex, or underlying medical conditions at enrollment on efficacy of RZV. 15 , 27 , 28 VE against HZ was 97.2% (95% CI: 91.4–99.5) in Europe, 96.1% (95% CI: 88.2–99.3) in Asia/Australia, 95.7% (95% CI: 83.7–100) in North America, and 96.3% (95% CI: 77.2–100) in Latin America in the ≥50-year-olds from the ZOE-50 study and 90.1% (95% CI: 82.0–95.1) in Europe, 95.1% (95% CI: 87.0–98.7) in Asia/Australia, 90.1% (95% CI: 77.0–96.5) in North America, and 87.3% (95% CI: 58.1–97.6) in Latin America among the ≥70-year-olds from the ZOE-50/70 studies. 15 Additionally, RZV vaccination reduced the loss of quality of life associated with both HZ and PHN and alleviated the severity of HZ-related pain in breakthrough HZ episodes.…”

Section: Discussionmentioning

confidence: 99%

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials

Kim

Diaz-Decaro

Jiang

et al. 2021

Human Vaccines & Immunotherapeutics

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In two large clinical trials (ZOE-50 [NCT01165177] and ZOE-70 [NCT01165229]), two doses of the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy (VE) against herpes zoster (HZ) in adults ≥50 years of age (YOA). This post-hoc analysis assessed the VE against HZ and postherpetic neuralgia (PHN), in participants from Asian study sites enrolled in ZOE-50/70. Reactogenicity and safety were also assessed. Participants ≥50 YOA were randomized 1:1 to receive 2 doses of either RZV or placebo, 2 months apart. VE was evaluated for a median follow-up of 4 years post-vaccination overall and by age in the ZOE-50 Asian population ≥50 YOA and in the pooled ZOE-50/70 Asian population ≥70 YOA. Of the 2,729 participants included in the ZOE-50 Asian population ≥50 YOA, 3 RZV and 66 placebo recipients reported a confirmed HZ episode. Overall VE was 95.6% (95% confidence interval [CI]: 86.4–99.1) against HZ and 100% (95% CI: 35.44–100) against PHN. In the pooled ZOE-50/70 Asian population ≥70 YOA, 4 RZV and 75 placebo recipients out of the 2,723 participants reported a confirmed HZ episode. Overall VE was 94.7% (95% CI: 85.9–98.6) against HZ and 89.8% (95% CI: 28.39–99.77) against PHN. Pain and myalgia were the most frequent solicited local and general adverse events, respectively, in both populations. No safety concern was identified during the study periods. RZV is highly efficacious against HZ and PHN and has an acceptable safety profile in Asian populations ≥50 YOA, similar to what was observed in the general ZOE-50/70 populations. Trademark statement : Shingrix is a trademark owned by or licensed to the GSK group of companies.

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Efficacy, Safety and Immunogenicity of a Novel Adjuvanted Subunit Herpes Zoster Vaccine in Japanese Aged 50 Years and 70 Years and Older

Cited by 5 publications

References 22 publications

The Potential Public Health Impact of Herpes Zoster Vaccination of People Aged ≥ 50 Years in Japan: Results of a Markov Model Analysis

The Potential Public Health Impact of Herpes Zoster Vaccination of People Aged ≥ 50 Years in Japan: Results of a Markov Model Analysis

Risk of herpes zoster in the Japanese population with immunocompromising and chronic disease conditions: Results from a claims database cohort study, from 2005 to 2014

The adjuvanted recombinant zoster vaccine is efficacious and safe in Asian adults ≥ 50 years of age: a sub-cohort analysis of the ZOE-50 and ZOE-70 randomized trials

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