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

Figures & data

Figure 1. Plain language summary

Table 1. Demographic characteristics of participants (total vaccinated cohort)

	ZOE-50 Asian population ≥50 YOA		Pooled ZOE-50/70 Asian population ≥70 YOA
	RZV (N = 1432)	Placebo (N = 1434)	RZV (N = 1471)	Placebo (N = 1472)
Number of participants, n (%)
Hong Kong	236 (16.5)	234 (16.3)	126 (8.6)	123 (8.4)
Japan	288 (20.1)	289 (20.2)	322 (21.9)	322 (21.9)
South Korea	268 (18.7)	271 (18.9)	331 (22.5)	335 (22.7)
Taiwan	640 (44.7)	640 (44.6)	692 (47.0)	692 (47.0)
Age at dose 1 (years±SD)	62.0 ± 9.1	62.0 ± 9.0	75.9 ± 4.7	76.0 ± 4.7
Female, n (%)	880 (61.5)	863 (60.2)	740 (50.3)	768 (52.2)

RZV, participants receiving the adjuvanted recombinant zoster vaccine; Placebo, participants receiving placebo; YOA, years of age; N, total number of participants; n (%), number (percentage) of participants in each category; SD, standard deviation

Figure 2. Vaccine efficacy against first or only episode of HZ by age and follow-up year in (A) ZOE-50 Asian population ≥50 YOA and (B) pooled ZOE-50/70 Asian population ≥70 YOA (modified total vaccinated cohort)

HZ, herpes zoster; RZV, participants receiving the adjuvanted recombinant zoster vaccine; Placebo, participants receiving placebo; YOA, years of age; N, number of participants; n, number of confirmed HZ episodes. *vaccine efficacy adjusted by age strata; ^#vaccine efficacy adjusted by age strata and region. Year 1, from 30 days to 395 days post-dose 2; Year 2, from >395 days to 760 days post-dose 2; Year 3, from >760 days to 1125 days post-dose 2; Year 4, from >1125 days post-dose 2 until last contact date. Error bars depict 95% confidence intervals.

Figure 3. Solicited local and general adverse events (AEs) reported within 7 days after vaccination in (A) ZOE-50 Asian population ≥50 YOA and (B) pooled ZOE-50/70 Asian population ≥70 YOA (TVC diary card sub-cohort)

RZV, participants receiving the adjuvanted recombinant zoster vaccine; Placebo, participants receiving placebo; TVC, total vaccinated cohort; YOA, years of age; GI, gastrointestinal symptoms; N, total number of participants; n, number of participants reporting the event. Error bars depict 95% confidence intervals.

Figure 4. Unsolicited adverse events, serious adverse events, and potential immune-mediated diseases in (A) ZOE-50 Asian population ≥50 YOA and (B) pooled ZOE-50/70 Asian population ≥70 YOA (total vaccinated cohort)

RZV, participants receiving the adjuvanted recombinant zoster vaccine; Placebo, participants receiving placebo; YOA, years of age; AE, adverse events; SAE, serious adverse events; pIMD, potential immune-mediated disease; N, total number of participants; n, number of participants reporting the event. *events recorded during the 30 days post-vaccination period. ^#Events recorded up to 12 months post-second dose. ^$Events recorded during the entire study period. See text for additional details.

Note: Error bars represent 95% confidence interval. Red bars indicate the number of participants with grade 3 unsolicited AEs.