Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
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.
Timeline
- Start
- 2019-09-03
- Primary completion
- 2021-12-23
- Completion
- 2021-12-23
Outcome
Met primary endpoint
paper The SYN023:HRIG ratio of geometric mean titer of RVNA (RVNA GMTs) on Day 8 (19.42) exceeded the 10 % superiority margin (P < 0.0001) PMID 38834432 ↗
paper The ratio of percent SYN023:HRIG recipients achieving RVNA ≥ 0.5 IU/mL on Day 99 (0.98) met the non-inferiority margin of 20 % (P = 0.013) PMID 38834432 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Human Rabies Immune Globulin | Protein / enzyme biologic | 20 iu/kg | Other |
| Subject | SYN023 | Monoclonal antibody | 0.3 mg/kg | Other |
| Background | Rabies vaccine | Vaccine | 1 ml | Intramuscular |