Comparison of safety and immunogenicity of purified chick embryo cell vaccine using Zagreb and Essen regimens in patients with category II exposure in China

Figures & data

Table 1. Safety comparison between the Zagreb and Essen regimens used in patients with WHO category II exposure to rabies

	Zagreb					Essen					P
	0–5 y old^#	6–18 y old	19–59 y old	60+ years old	Total	0–5 y old^#	6–18 y old	19–59 y old	60+ years old	Total
Sex, M/F	11/14	15/17	18/20	15/22	59/73	12/16	17/12	18/19	14/18	61/65	0.907
Mean age (SD)^‡	41.92 (11.66) m	15.22 (3.12) y	46.26 (11.12) y	73.49 (7.37) y	38.13 (27.08) y	37.18 (12.53) m	14.48 (2.84) y	43.68 (11.76) y	69.56 (5.81) y	35.83 (26.48) y	0.459
Systemic symptoms (occurring during first immunization)*	16(15)	5(5)	2(2)	4(4)	27(26)	12(10)	3(3)	2(2)	3(3)	20(18)	0.341
Fever	12	1	1	1	15	8	2	1	1	12
Malaise	0	2	1	2	5	0	0	0	2	2
Allergy	1	1	0	0	2	2	0	1	0	3
Restlessness	0	1	0	0	1	1	1	0	0	1
Nausea and vomiting	2	0	0	0	2	1	0	0	0	1
Diarrhea	1	0	0	1	2	0	0	0	0	0
Local symptoms (occurring during first immunization)*	5(5)	14(12)	5(4)	16(13)	40(34)	5(5)	13(9)	4(3)	12(10)	34 (27)	0.556
Pain	1	9	3	11	24	0	10	2	6	18
Induration	2	2	1	0	5	2	1	0	2	5
Edema	1	1	0	1	3	1	1	1	1	4
Tenderness	1	2	1	3	7	1	1	1	3	6
Erythema	0	0	0	1	1	1	0	0	0	1

*Data in brackets show the number of side effects after first immunization, which have no significant differences of total side effects incidence between Zagreb and Essen in systemic symptoms (P = 0.383, 26/27 vs 18/20) or local symptoms (P = 0.529, 34/40 vs 27/34). ^#Although the difference in side effects of <5-y-old patients between Zagreb and Essen (P = 0.060, 21/25 vs 17/28) was not statistically significant, it was found to be statistically significant after the first-dose immunization (P =0.043, 20/25 vs 15/28). ^‡m, months; y, years.

Figure 1. The difference in immunogenicity between Zagreb and Essen groups before (day 0) and after rabies vaccination. Zagreb showed significantly higher rabies neutralization antibody titers (P < 0.001) and seroconversion rate (P = 0.0114) than Essen at day 7 post-vaccination, but had lower rabies neutralization antibody titers at days 45 and 365 post-vaccination. The data shown are the mean ± 95% confidence interval (*P < 0.001).

Figure 2. Flowchart of the safety and immunogenicity study.