Comparison of safety and immunogenicity of 2 WHO prequalified rabies vaccines administered by one week, 4 site intra dermal regimen (4-4-4-0-0) in animal bite cases

Figures & data

Table 1. Socio demographic characteristics of study subjects

Characteristics		Rabipur group (n = 45)	Verorab group (n = 44)
Mean Age (±SD) in Years		32.3 ± 11.7	31.1 ± 10.4
Sex	Male	29 (64.4)	28 (63.6)
	Female	16 (35.6)	16 (36.4)
Education	Higher Secondary and above	21 (46.7)	20 ( 45.5)
Occupation	Employed/working	33 (73.3)	32 (72.7)
Socio Economic Status	Middle and above	41 (91.1)	40 (90.9)

Note: Figures in parenthesis indicate percentages.

Table 2. Distribution of study subjects according to the details of exposure

Characteristics		Rabipur group (n = 45)	Verorab group (n = 44)
Biting animal	Dog	43 (95.6)	39 (88.6)
	Cat	02 (4.4)	04 (9.1)
	Monkey	-	01 (2.3)
Type of biting animal	Stray	29 (64.4)	22 (50.0)
Vaccination Status of biting animal	Not known	30 (66.6)	23 (52.3)
Classification of biting animal	Suspect rabid	45 (100)	44 (100)
Fate of biting animal	Available	28 (62.2)	31 (70.5)
Category of exposure	III	39 (86.7)	37 (84.1)
Site of bite	Lower limb	31 (68.9)	26 (59.1)

Note: Figures in parentheses indicate percentages.

Table 3. Comparison of adverse drug events of study vaccines

Type of adverse drug events*	Rabipur group (n = 45)	Verorab group (n = 44)
Local
Itching	04 (0.74)	01 (0.19)
Erythema	06 (1.11)	02 (0.38)
Pain	02 (0.37)	02 (0.38)
Systemic
Fever	02 (0.37)	—
Myalgia	02 (0.37)	—
Regional Lymphadenopathy	—	01 (0.19)
Total	16/540(2.96)	06/528(1.14)
Z – value	2.101
p –value	<0.05

Note: Figures in parenthesis indicate percentages.

* Multiple responses;

** 45 subjects × 3 doses × 4 sites;

*** 44 subjects × 3 doses × 4 sites.

Table 4. Comparison of geometric mean RVNA concentration following administration of Rabipur or Verorab using one week, 4 site ID regimen in animal bite cases

Day of blood sample	Vaccine	No. of subjects	Range (IU/mL)	GMC (IU/mL)	95% CI		t-value	P value
					Lower Bound	Upper Bound
14	Rabipur	45	4.5–16.5	14.50	13.50	15.57	0.095	0.924
	Verorab	44	4.5–16.5	14.43	13.41	15.53
90	Rabipur	42	6.5–14.5	11.78	11.27	12.31	0.432	0.667
	Verorab	43	10.5–14.5	11.93	11.47	12.40
365	Rabipur	32	4.5–8.5	5.95	5.50	6.44	0.933	0.354
	Verorab	38	4.5–7.5	5.67	5.29	6.08

Note: GMC- Geometric Mean Concentration; CI- Confidence Interval.

Table 5. Inclusion and Exclusion criteria for enrolling subjects in the study

	Inclusion Criteria		Exclusion Criteria
1	Subjects aged 18 years and below 55 years of age	1	Subject who has received any type of rabies vaccination in the past.
2	Subjects with either category II or category III exposures to rabies	2	Pregnancy and lactation
3	Subjects willing to sign informed consent	3	Subject has received rabies immunoglobulin (human/equine) in the past
4	Subjects available for one year follow-up period and willing to give blood samples on recommended days	4	Subject is suffering from chronic diseases like diabetes mellitus, hypertension and tuberculosis
5	Subject with animal bite cases reported within 72 hours of exposure	5	Subject on steroids, anticancer drugs and radiation therapy or any other immunosuppressant or immune compromised
		6	Subject is on concomitant antimalarial drugs
		7	Subject with history of allergy to any ingredient of the vaccine
		8	Subject in other clinical trial in the past 3 months