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

Abstract

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.

Safety and reactogenicity of the adjuvanted recombinant zoster vaccine: experience from clinical trials and post-marketing surveillance

“… 21 In Asian populations ⩾50 years of age, RZV has an acceptable safety profile, similar to what was observed in the general ZOE-50/70 populations. 26 …”

Real-world effectiveness of recombinant zoster vaccine in self-identified Chinese individuals aged ≥50 years in the United States

“…The general population has a lifetime risk of developing HZ of approximately 30%; this risk increases rapidly in adults older than 50 years of age. 26 Two clinical trials showed high efficacy of RZV against HZ, 7 , 8 with post-hoc analyses demonstrating similar efficacy in the subgroup of Asian subjects 18 and across geographic regions and ethnic groups. 27 The vaccine was licensed for use in the U.S. and China in the general population aged ≥50 years.…”

“… 17 However, the RZV clinical trials included Asian countries, and a post-hoc analysis of vaccine efficacy was conducted in Asian adults, which demonstrated similar efficacy as the overall study. 18 Recently, a post-licensure trial in China found a vaccine efficacy against HZ of 100% in adults aged ≥50 years. Although there are data on vaccine efficacy in Chinese adults, there are no real-world effectiveness data in Chinese adults.…”

Public health impact of herpes zoster vaccination on older adults in Hong Kong

“… 37 , 38 Additionally, there was no variation in RZV vaccine efficacy by ethnicity in the Asian population, confirmed by an Asian subgroup analysis of global ZOE-50 and ZOE-70 trial data. 52 …”