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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
448
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
University of Florida
Gainesville, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Clinical Research Solutions PC -Milan
Milan, Tennessee, United States
University of Virginia
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Baguio General Hospital and Medical Center
Baguio City, Benguet, Philippines
De La Salle Health Sciences Institute Independent Ethics Committee
Cavite City, Calabarzon, Philippines
Southern Philippines Medical Center
Davao City, Davao (Region XI), Philippines
Manila Doctors Hospital Institutional Review Board
Manila, National Capital Region, Philippines
Asian Hospital and Medical Center
Muntinlupa, National Capital Region, Philippines
...and 4 more locations
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 8
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 99
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 99
Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) ≥0.5 IU/mL at Study Day 99
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 99
Number of Probable or Confirmed Rabies Cases
Case Classification Human Rabies * Suspected: A case that is compatible with the clinical case definition * Probable: A suspected case (above) plus history of contact with a suspected rabid animal. * Confirmed: A suspected case that is laboratory-confirmed.
Time frame: Day 1 to Day 365
Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 4
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT).
Time frame: Day 4
Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA)
Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 1 to Day 15 after administration (AUEC1-15)
Time frame: Day 1 to Day 15
Maximum Observed Serum Concentration (Cmax)
The Cmax of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
Time of Maximum Observed Serum Concentration (Tmax)
The Tmax of CTB011 and CTB012 derived from non-compartmental analysis.
Time frame: Day 1 to Day 99
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