Safety and immunogenicity of rabies vaccine as 4 - dose Essen Intramuscular regimen for post exposure prophylaxis: A non - randomized, comparative controlled study

Figures & data

Table 1. Details of exposure

Details of exposure	4-dose Essen IM regimen(n=35)	5-dose Essen IM regimen(n=35)
Biting animal (Dog)
Stray	0 (0.0)	35 (100.0)
Pet	35 (100.0)	0 (0.0)
Category of exposure
II	5 (14.3)	3 (08.6)
III	30 (85.7)	32 (91.4)
Site of bite
Head & neck	0 (0.0)	2 (05.7)
Trunk	2 (05.7)	4 (11.4)
Upper limb	10 (28.6)	11 (31.4)
Lower limb	23 (65.7)	18 (51.4)
Type of wounds
Abrasion	30 (85.7)	20 (57.1)
Laceration	4 (11.4)	9 (25.7)
Puncture wound	1 (02.9)	6 (17.1)
Wound wash following bite at home
Yes	32 (91.4)	26 (74.3)
No	3 (08.6)	9 (25.7)
Application of local irritant
Yes	0 (0.0)	2 (05.7)
No	35 (100.0)	33 (94.3)

Figures in parenthesis indicates percentages

Table 2. Usage of rabies immune-biologicals

Rabies immune-biologicals	4-dose Essen IM regimen(n=35)	5-dose Essen IM regimen(n=35)
Type of vaccine given
Rabipur (PCECV)	33 (94.3)	34 (97.2)
Verorab (PVRV)	2 (05.7)	1 (02.8)
Rabies immunoglobulin administered
Yes	30 (85.7)	32 (91.4)
No	5 (14.3)	3 (08.6)
Type of RIG administered
Equine RIG	28 (93.3)	31 (96.9)
Human RIG	2 (06.7)	1 (03.1)
Site of RIG administration
Local	19 (63.3)	18 (56.3)
Both local & systemic	11 (36.7)	14 (43.7)

Figures in parenthesis indicates percentages

Table 3. Adverse drug events among the study groups

Adverse drug events	4-dose Essen IM regimen (n=35)*	5-dose Essen IM regimen (n=35)**
Erythema	7 (5.0%)	6 (3.5%)
Itching	2 (1.4%)	3 (1.7%)
Pain	1 (0.7%)	2 (1.2%)
Induration	1 (0.7%)	1 (0.6%)
Total	9/132 (7.0%)	12/173 (6.9%)
P - value	P > 0.05

*35 subjects X 4 doses = 140 **33 subjects X 5 doses (– 2 dropouts) = 173

Table 4. RVNA response to post exposure vaccination

						95% CI for GMC
Day	Study groups	Subjects (n)	GMC	GSD	SE (GMC)	Lower bound	Upper bound	t-value	P-value
14	4-dose Essen IM regimen	35	10.2	2.1	1.1	7.8	13.6	1.668	>.1
	5-dose Essen IM regimen	34	12.5	2.4	1.2	9.1	18.1
90	4-dose Essen IM regimen	34	24.9	1.4	1.1	21.3	26.4	1.972	>.5
	5-dose Essen IM regimen	33	27.9	1.3	1.1	24.5	34.7
180	4-dose Essen IM regimen	34	9.5	1.7	1.6	6.2	12.7	1.048	>.29
	5-dose Essen IM regimen	33	10.6	2.1	1.8	6.9	14.3

GMC, Geometric Mean Concentration; GSD, Geometric Standard Deviation; SE, Standard Error; CI, Confidence Interval

Figure 1. RVNA response to post exposure vaccination

GMC: Geometric Mean Concentration.