KEDRAB Rx

The efficacy of Kedrab given concurrently with the rabies vaccine was studied in a single-center, randomized, comparator human rabies immune globulin (HRIG)-controlled clinical study. Patients were healthy adults 18–72 years of age who had no significant acute or chronic illness. A total of 118 patients (59 per treatment group) received intramuscular Kedrab or comparator HRIG at a dose of 20 IU/kg on Day 0, and rabies vaccine on Days 0, 3, 7, 14 and 28. The mean age of study patients was 45 years. 

• The efficacy variable was rabies virus neutralizing activity (RVNA), as assessed by Rapid Fluorescent Focus Inhibition Test (RFFIT), on Day 14.
• Efficacy analyses were performed on the As-Treated Population, which comprised 116 study patients who received Kedrab or comparator HRIG and at least 3 of the 5 doses of rabies vaccine before Day 14.
• Efficacy, considered when RVNA titer is 0.5 IU/mL or higher on Day 14 (as established by the WHO), was met by 56/57 patients (98.2%) in the Kedrab group versus 59/59 patients (100%) in the comparator HRIG group. The lower limit of the 90% CI was greater than the pre-specified non-inferiority margin of -10%; thus, Kedrab was non-inferior to comparator HRIG.

Kedrab was also evaluated in a two-center, open-label clinical trial in 30 pediatric patients exposed or possibly exposed to rabies virus for whom post-exposure prophylaxis was indicated. Patients were treated with Kedrab at a dose of 20 IU/kg on Day 0 and active rabies vaccine on Days 0, 3, 7, and 14 as per ACIP recommendations for rabies post-exposure prophylaxis. The patients ranged in age from 0.5–14.9 years. 

• The efficacy variables were RVNA as assessed by RFFIT on Day 14 and occurrence of rabies disease through Day 84 after administration of Kedrab.
• Efficacy analyses were performed on the As-Treated Population, which comprised all 30 study patients.
• In the As-Treated Population, the geometric mean (SD) Day-14 RVNA titer was 18.89 (31.61) IU/mL and the median Day-14 RVNA titer was 8.81 (range 0.21–153.62) IU/mL.
• Of the 30 treated pediatric patients, 28 patients (93.3%) had a Day-14 RVNA titer ≥0.5 IU/mL, the WHO recommended level. None of the 28/30 patients who were followed for the duration of the study developed rabies infection through day 84.