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RABIPUR · 2 trials · 1 indication
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be better than a classic course with control commercialized vaccine.
Assessment of safety based on the identification of any adverse events for all the treatment groups, Group A, Group B and Group C through to the end of the study at day 42.
To analyze the titer level of RVNA from serum at day 14 and 42 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
| Arm | Type | Description |
|---|---|---|
| RABIPUR® | ACTIVE_COMPARATOR | Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| PIKA Rabies vaccine | EXPERIMENTAL | PIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose) |
| Group A | ACTIVE_COMPARATOR | Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| Group B | EXPERIMENTAL | PIKA Rabies vaccine Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14 |
| Group C | EXPERIMENTAL | PIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose) |
| Name | Type | Description |
|---|---|---|
| RABIPUR® | BIOLOGICAL | Biological rabies vaccine |
| PIKA rabies vaccine | BIOLOGICAL | Biological rabies vaccine |
| PIKA rabies vaccine with an accelerated regimen | BIOLOGICAL | Biological rabies vaccine |
Inclusion Criteria: * Informed consent form has been signed and dated * Able to attend all scheduled visits and comply with all trial procedures. * Never received rabies vaccine before. * Refrain from blood donation during the course of the study. * Able to attend all scheduled visits and comply wi...
RABIPUR is a monoclonal antibody being developed for rabies, an infectious disease. It is currently in Phase 2 clinical development and is intended for use in preventing or treating rabies infection.
RABIPUR is being developed by LakeShore Biopharma Co., Ltd, a company listed on the stock exchange under the ticker symbol LSB.
RABIPUR is in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 and a Phase 2 study, and is not yet approved by regulatory authorities.
RABIPUR has been studied in two completed clinical trials. NCT02657161 was a Phase 1 study with 37 participants, and NCT02956421 was a Phase 2 study with 126 participants, both conducted in Singapore.
RABIPUR is associated with the PIKA rabies vaccine platform. The clinical trials for RABIPUR evaluated a PIKA rabies vaccine containing the PIKA adjuvant, suggesting RABIPUR may be the vaccine candidate itself.