NCT02040090

Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects

A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Efficacy of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) and Active Rabies Vaccine in Healthy Subjects

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Kamada, Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Rabies

Interventions

Type	Name	Description
DRUG	Active rabies vaccine (US-FDA approved)	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.

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2014-01-20
• Last updated: 2021-09-29
• Results posted: 2021-09-29

Locations

1 site across 1 country: United States