Immunogenicity and safety of purified vero cell rabies vaccine (PVRV) produced by Liaoning Cheng Da Co. under Zagreb 2-1-1 or 5-dose Essen regimen in Chinese adults aged 50 and above

Figures & data

Figure 1. Flow diagram of the trial.

Table 1. Socio demographic characteristics of subjects.

	Zagreb regimen	Essen regimen	p
Number of subjects	57	50
Age(years)
Mean ± SD	61.7 ± 8.2	59.6 ± 6.3	0.1
Variation	50–78	50–79
<65 /≥65 y ration	41/16	42/8	0.1
Male/female ratio	27/30	22/28	0.7

Table 2. Immunogenicity.

			RVNA response (IU/ml)
Days	Regimen	No. of subjects	Range	GMC	N ≥ 0.5 (IU/ml)	Seroconversion (%)
D0	Zagreb	57	0.01–0.04	≤ 0.04	0	0.00
	Essen	50	0.01–0.04	≤ 0.04	0	0.00
D7	Zagreb	57	0.06–3.87	0.33^&	7	12.28
	<65	42	0.06–3.87	0.41	7	16.67
	≥65	15	0.08–0.41	0.12	0	0.00
	Essen	50	0.08–12.71	0.56	5	10.00
	<65	42	0.08–12.71	0.65	5	11.90
	≥65	8	0.08–0.14	0.09	0	0.00
D14	Zagreb	57	0.54–23.68	3.78^#	57	100.00
	<65	42	0.79–23.68	4.61	42	100.00
	≥65	15	0.79–5.68	1.46	15	100.00
	Essen	50	0.88–36.75	5.62	50	100.00
	<65	42	0.98–36.75	6.23	42	100.00
	≥65	8	0.88–7.60	2.45	8	100.00
D42	Zagreb	57	1.29–36.75	10.02	57	100.00
	<65	42	1.29–36.75	10.83	42	100.00
	≥65	15	1.29–25.59	7.76	15	100.00
	Essen	50	1.36–38.12	14.38	50	100.00
	<65	42	2.38–38.12	15.28	42	100.00
	≥65	8	1.36–21.40	9.63	8	100.00
D180	Zagreb	57	0.05–45.79	4.06^&	41	71.93^#
	<65	42	0.05–45.79	5.00	37	88.10
	≥65	15	0.05–9.53	1.41	4	26.67
	Essen	50	0.06–12.71	2.37^#	32	64.00^$
	<65	42	0.09–12.71	2.76	31	73.81
	≥65	8	0.06–0.71	0.28	1	12.50
D365	Zagreb	48	0.09–20.80	1.87	29	60.42^&
	<65	37	0.09–20.80	2.08	26	70.27
	≥65	11	0.09–7.13	1.17	3	27.27
	Essen	27	0.07–15.09	2.18	16	59.26
	<65	26	0.07–15.10	2.26	16	61.54
	≥65	1	0.26	0.26	0	0.00

Note:

^& Comparison of GMC or seroconversion in one regimen group by age <<65 and ≥65 y cohort p < 0.05;

^$ Comparison of GMC or seroconversion in one regimen group by age <65 and ≥65 y cohort p < 0.01

^# Comparison of GMC or seroconversion in one regimen group by age <65 and ≥65 y cohort p < 0.001.

Table 3. Comparison of AEs incidences between 2 regimens.

	Zagreb regimen					Essen regimen
Total number	57 × 3					50 × 5
Time(hours)	≤12	13–24	25–48	49–72	73–672^*	≤12	13–24	25–48	49–72	73–840^#
Local AEs, n
pain	13	2	0	0	0	9	0	1	1	10
pruritus	1	0	0	0	0	1	0	0	0	0
edema	0	0	0	0	0	1	0	2	0	4
induration	0	0	0	0	0	0	0	0	0	1
erythema	2	0	0	0	0	0	0	2	0	1
Total n (%)	18(10.5)				0^+(0.0)	17(6.8)				16(6.4)
Systemic AEs, n
fever	0	0	0	0	0	0	0	0	0	0
myalgia	0	0	0	0	0	0	0	0	0	1
malaise	1	0	0	0	0	0	0	0	0	0
nausea	1	0	0	0	0	0	0	0	0	0
fatigue	6	0	0	0	0	5	0	0	1	3
Loss of appetite	0	0	0	0	0	0	0	0	0	1
headache	0	0	0	0	0	0	0	0	0	0
Total n (%)	8(4.7)				0(0.0)	6(2.4)				5(2.0)
Total n (%)	26(15.2)				26(15.2)	23(9.2)				44(17.6)

Note:

* ,AEs after the day-3 to the day-(21+7)

^# ,AEs after the day-3 to the day-(28+7);

⁺ ,p = 0.002 compare with Essen regimen ( Fisher).

Figure 2. Rabies virus neutralizing antibody concentrations (GMC) in all subjects in the Zagreb and Essen regimens on Day 7, 14, 42,180 and 365.

Figure 3. Rabies virus neutralizing antibody concentrations (GMC) in the Zagreb and Essen regimens on Day 0, 7, 14, 42,180 and 365. Error bars and values in parenthesis represent 95% CI.

Figure 4. Percentage of subjects with AEs in Zagreb and Essen regimens in 3 and 7 d after the first vaccination compared by age cohort.

Figure 5. Percentage of subjects with AEs in Zagreb and Essen regimens in 3 and 7 d after the first vaccination compared by gender cohort.