Conditions: Rabies
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 118
Healthy volunteers: yes

Brief summary:
The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.

Detailed description:
This is a prospective, randomized, double-blind, and single period non-inferiority and safety study conducted at a single study site. Subjects were randomized into the following two groups:

Group A: KamRAB (20 IU/kg by weight \[bw\]) intramuscular (IM), rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM Group B: Human rabies immune globulin (HRIG) Comparator product (20 IU/kg bw) IM, rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM The primary endpoint was a dichotomous (0-1) variable, defined by reaching an anti-rabies immunoglobulin G (IgG) concentration ≥0.5 IU/mL on Day 14. The primary hypothesis was that the proportion of KamRAB + vaccine recipients with anti-rabies concentration ≥0.5 IU/mL on Day 14 would not be less than the corresponding proportion of HRIG Comparator subjects by as much as 0.1.

The safety and tolerability of the study treatments was assessed based on: vital signs and physical examination findings, electrocardiogram (ECG), laboratory findings (hematology, clinical chemistry, and urinalysis) and the occurrence of adverse events (AEs) after drug administration

Arms:
arm 1: KamRAB 20 IU/kg body weight via IM injection, once on Day 0 arm 2: Comparator product: Intramuscular (IM) injection once on Day 0 in the same manner and at the same dosage as KamRAB.

Interventions: intervention 1: Active rabies vaccine (US-FDA approved)
Intervention descriptions: intervention 1: A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.

Protocol document: