Safety and efficacy of rabies immunoglobulin in pediatric patients with suspected exposure

Figures & data

Table 1. Demographics of the Study Population.

Age, y	Mean ± SD	7.45 ± 4.3
	Median	7.15
	Range (min – max)	0.5–14.9
Sex, no. (%)	Female	14 (46.7)
	Male	16 (53.3)
Race, no. (%)	White	21 (70)
	Black/African American	7 (23.3)
	Asian	2 (6.7)
Ethnicity, no. (%)	Hispanic or Latino	3 (10.0)
	Not Hispanic or Latino	27 (90.0)
Weight, kg	Mean ± SD	32.61 ± 21.83
	Median	22.25
	Range (min – max)	6.6–85.7
Height, cm	Mean ± SD	122.68 ± 31.03
BMI, kg/m^2	Mean ± SD	19.19 ± 4.48

SD, standard deviation; min – max, minimum to maximum; BMI, body mass index.

Table 2. Incidence of adverse events within 14 days of treatment of 30 patients with KEDRAB.

A.
Serious AE	Number of subjects (%)
Serious AE	0 (0.0)
Deaths	0 (0.0)
TEAE: any cause TEAE: by severity Mild Moderate Severe TEAE: treatment related TEAEs leading to discontinuation	21 (70.0) 21 (70.0) 0 (0.0) 0 (0.0) 12 (40.0) 0 (0.0)
B.
	Number of TEAEs (% of subjects with TEAEs) [N = 30]
Individual TEAEs	Any cause^a	Treatment related^b
Injection-site pain	9 (26.7)	5 (16.6)
Injection-site erythema	2 (3.3)	1 (3.3)
Fatigue	2 (6.7)	2 (6.7)
Vomiting	2 (6.7)	1 (3.3)
Pyrexia	2 (6.7)	1 (3.3)
Body temperature increased	3 (6.7)	1 (3.3)
Headache	4 (13.3)	1 (3.3)
Ecchymosis	2 (6.7)	1 (3.3)
Arthropod bite	4 (10.0)	0 (0.0)
Contusion	2 (6.7)	0 (0.0)
Pain in extremity	3 (10.0)	0 (0.0)
Anxiety	2 (6.7)	0 (0.0)

A. Incidence of adverse events within 14 days of treatment. B. Local and systemic TEAEs with incidence >1 recorded during the 14 days following administration of HRIG150; data are based on the safety population.

^aAny-cause AEs include events assessed as having “probable,” “possible,” “unlikely,” or “unrelated” relation to the study treatment. These AEs occurred on or after HRIG150 administration, or were a pre-treatment event or preexisting medical condition that worsened in intensity after HRIG150 administration. ^bRelated AEs are those assessed as having “probable” or “possible” relation to the study treatment.

AE, adverse event; TEAE, treatment-emergent adverse event.

Table 3. Efficacy.

Participants free of active rabies infection, no. (%)
At day 14	30 (100)
At day 84	30 (100)
RVNA titer
No. of participants with RVNA titer ≥0.5 IU/mL at day 14	28 (93.3)
Mean ± SD	18.89 ± 31.61
Median	8.81
Range (min – max)	0.21–153.62

Percentages are based on the number of participants in the as-treated population. RVNA titers denote the geometric mean of the results per participant per visit.²⁷

min – max, minimum to maximum; RVNA, rabies virus neutralizing antibody; SD, standard deviation.

Matson MA, Schenker E, Stein M, Zamfirova V, Nguyen H-B, Bergman GE. Safety and efficacy results of simulated post-exposure prophylaxis with human immune globulin (HRIG; KEDRAB) co-administered with active vaccine in healthy subjects: a comparative phase 2/3 trial. Hum Vaccin Immunother. 2020;16(2):452–59. doi:10.1080/21645515.2019.1656967.

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