At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults With Different Rabies Exposure Risks
In Brief
A Phase 2 clinical trial evaluating SYN023, HRIG (HyperRab), and 1 other intervention for Rabies. Completed, enrolled 448 participants across 14 sites in 2 countries.
Detailed Summary
This is a Phase 2b, double blinded, randomized study of SYN023 compared to HyperRab® (a licensed Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll sequentially two different risk substrata of WHO Category 3 rabies exposure which are Low Risk Group (LRG) and Normal Risk Group (NRG). The enrollment will be stepwise while subject's data will be reviewed by data and safety monitoring board (DSMB) to confirm the safety and permit for next enrollment. Besides, rabies vaccine would be administered within 75 minutes after Study Drug in each group. This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in the United States.
Study Details
Timeline
Arms & Interventions
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). Bites to the head, neck, genitalia arm or hand are not included in the LRG. The initial 20 subjects in the LRG were to be randomized on a 3:1 (SYN023 to Human Rabies Immune Globulin (HRIG)) ratio. The general 60 subjects in the LRG were to be allocated with a 1:1 randomization to either SYN023 or HRIG treatment arms. SYN023: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 0.3 mg/kg of SYN023 * Frequency/duration: at Day 1 Rabies vaccine: * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: Initial LRG subjects received 4 vaccine doses (Days 1, 4, 8,15); General LRG subjects received 5 vaccine doses (Days 1, 4, 8, 15, and 29).
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). Bites to the head, neck, genitalia arm or hand are not included in the LRG. The initial 20 subjects in the LRG were to be randomized on a 3:1 (SYN023 to Human Rabies Immune Globulin (HRIG)) ratio. The general 60 subjects in the LRG were to be allocated with a 1:1 randomization to either SYN023 or HRIG treatment. HRIG: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 20 IU/kg * Frequency/duration: at Day 1 Rabies vaccine : * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: Initial LRG subjects received 4 vaccine doses (Days 1, 4, 8,15); General LRG subjects received 5 vaccine doses (Days 1, 4, 8, 15, and 29)
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). The NRG were consisted of all WHO Category 3 exposure. Subjects were to be allocated with a 1:1 randomization to either SYN023 or Human Rabies Immune Globulin (HRIG) treatment arms. SYN023: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 0.3 mg/kg of SYN023 * Frequency/duration: at Day 1 Rabies vaccine: * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: at Day 1, 4, 8, 15, 29
The subjects were enrolled in the study sequentially into 2 different risk substrata of WHO Category 3 rabies exposure, which included Low Risk Group (LRG) and Normal Risk Group (NRG). The NRG were consisted of all WHO Category 3 exposure. Subjects were to be allocated with a 1:1 randomization to either SYN023 or Human Rabies Immune Globulin (HRIG) treatment arms. HRIG: * Interventions: are administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible * Dosage: 20 IU/kg * Frequency/duration: at Day 1 Rabies vaccine (RabAvert/Rabipur): * Interventions: should be administered in deltoid muscle * Dosage: 1 mL after reconstitution * Frequency/duration: at Day 1, 4, 8, 15, 29
Interventions
it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
it should be administered in deltoid muscle