Immunogenicity and safety of an adjuvanted herpes zoster subunit candidate vaccine in adults ≥ 50 years of age with a prior history of herpes zoster: A phase III, non-randomized, open-label clinical trial

Figures & data

Figure 1. Study flow.

Table 1. Characteristics of study participants (Total vaccinated cohort).

Characteristic	Parameters/Categories	Total N = 96	50–59 YOA N = 32	60–69 YOA N = 32	≥ 70 YOA N = 32
Age	Mean (± SD)	64.9 (± 10.2)	53.7 (± 2.9)	64.4 (± 2.8)	76.8 (± 5.2)
Gender	Female n (%)	63 (65.6)	24 (75.0)	19 (59.4)	20 (62.5)
Geographic ancestry	Caucasian/European heritage n (%)	92 (95.8)	31 (96.9)	30 (93.8)	31 (96.9)
	Central/South Asian heritage n (%)	2 (2.1)	1 (3.1)	1 (3.1)	0 (0.0)
	Japanese heritage n (%)	1 (1.0)	0 (0.0)	0 (0.0)	1 (3.1)
	Arabic/North African heritage n (%)	1 (1.0)	0 (0.0)	1 (3.1)	0 (0.0)
Time since previous HZ episode	≤ 4 years	65 (67.7)	26 (81.3)	22 (68.8)	17 (53.1)
	5–9 years	18 (18.8)	3 (9.4)	6 (18.8)	9 (28.1)
	≥ 10 years	13 (13.5)	3 (9.4)	4 (12.5)	6 (18.8)

50–59 YOA = 50–59 year-old participants; 60–69 YOA = 60–69 year-old participants; ≥ 70 YOA = participants over 70 y of age; SD = standard deviation; N = total number of participants; n (%) = number (percentage) of participants in a given category; HZ = Herpes Zoster.

Figure 2. Vaccine response rates for anti-gE antibody concentrations one month after the second vaccine dose: overall, by age group and by time since previous herpes zoster episode (ATP cohort for immunogenicity).

Table 2. Vaccine response rates and geometric mean concentrations of anti-gE antibodies at Month 0 and Month 3 (ATP cohort for immunogenicity).

				GMC (95% CI)
Characteristic	Category	N	VRR (95% CI)	PRE	PII (M3)
Overall		82	90.2 (81.7–95.7)	2398 (1779–3233)	47,759 (42,259–53,974)
By age group	50–59 YOA	29	89.7 (72.6–97.8)	2561 (1531–4284)	56,414 (43,783–72,688)
	60–69 YOA	28	92.9 (76.5–99.1)	2084 (1357–3198)	44,471 (37,373–52,916)
	≥ 70 YOA	25	88.0 (68.8–97.5)	2601 (1319–5126)	42,643 (34,699–52,405)
By time since previous HZ episode	≤ 4 Years	54	85.2 (72.9–93.4)	3490 (2359–5163)	50,441 (43,443–58,567)
	5–9 Years	17	100 (80.5–100)	1148 (729–1805)	41,057 (32,324–52,151)
	≥ 10 Years	11	100 (71.5–100)	1187 (703–2005)	46,135 (28,397–74,955)

N = total number of participants; 95% CI = 95% confidence interval; VRR = vaccine response rate; GMC = geometric mean concentration; PRE = pre-vaccination; PII (M3) = 1 month post-dose 2 (Month 3); 50–59 YOA = 50–59 year-old participants; 60–69 YOA = 60–69 year-old participants; ≥ 70 YOA = participants over 70 y of age; ≤ 4 Years = ≤ 4 y since previous herpes zoster episode; 5–9 Years = 5–9 y since previous herpes zoster episode; ≥ 10 Years = ≥ 10 y since previous herpes zoster episode; HZ = Herpes Zoster.

Figure 3. Incidence of solicited local (A) and general (B) adverse events (total vaccinated cohort, overall/participant).

Table 3. Overview of suspected HZ episodes reported during the study (total vaccinated cohort).

							Anti-gE concentration
Case no.	Age group	Occurrence of previous episode^*	Previous vaccine dose(s)	Day of onset^†	Duration (days)	AE description	Month 0	Month 3	Medical advice/ Medically attended visit	Outcome at study end
1	60–69 YOA	<4	2	288	12	Herpes zoster	18,029	79,425	Y^**	Resolved
2	60–69 YOA	5–9	2	131	8	Shingles	1812	84,604	N	Resolved
3	60–69 YOA	5–9	1	178	15	Herpes zoster of neck and posterior occipital pain	2702	26,659	Y	Resolved
4^a	≥ 70 YOA	>10	2	178	9	Herpes zoster left ear and head - Small erythematous rash behind left ear, very swollen red rash	1908	69,989	Y	Resolved
5^a			2	204	14	Herpes zoster			Y	Resolved
6	≥ 70 YOA	<4	1	56	31	Right flank - Herpes zoster	1646	ND	Y	Resolved
7^b	≥ 70 YOA	>10^**	1	28	5	Herpes zoster left back	350	2319	N	Resolved
8^b			1	54	193	Herpes zoster left back			Y^**	Resolved
9^b			1	430		Herpes zoster left back			N	Ongoing

Footnote:

^a,b Multiple herpes zoster episodes reported by the same participant (1 participant with 2 episodes and 1 participant with 3 episodes).

YOA = Years of Age

* Presented as number of years before study start

** Information collected after data lock point

^† Days from the last vaccine dose