Rabies Post-exposure Prophylaxis Clinical Trial
Official title:
A Phase III Clinical Trail to Evaluate the Efficacy,Safety,Pharmacokinetics and Immunogenicity Characteristics of GR1801 Injection for the Post-exposure Prophylaxis (PEP) of WHO Category 3 Rabies Exposure Patients.
The goal of this clinical trial is to compare the efficacy and safety of GR1801 injection with Human Rabies Immunoglobulin(HRIG) in patients with WHO Category 3 rabies exposure. Patients will receive GR1801 injection or HRIG. Each group will receive rabies vaccine as the WHO Essen regime after Study Drug.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | July 1, 2024 |
Est. primary completion date | September 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Chinese males or females aged 18 years or above on Study Day 0 with legal identification documents and plan to live in the local area during the study; 2. WHO Category III rabies exposure; 3. Those who have an armpit temperature = 37.0 °C; 4. Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups. Exclusion Criteria: 1. WHO Category III rabies exposure but received wound suture treatment; 2. WHO Category III rabies exposure over 72 hours; 3. Previous receipt of rabies vaccination or rabies passive immunization; 4. History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0; 5. History of any severe allergy for vaccination; 6. Had fever (armpit temperature = 38.5 °C) or received any antipyretic, analgesic or anti-allergic drug within 3 days before Study Day 0; 7. History of severe autoimmune diseases; 8. History of any severe neurological disease; 9. History of receiving any immunoglobulin or vaccine within 30 days before Study Day 0, or plan to use any such product during the study; 10. History of addiction to any narcotic, alcohol or drugs; 11. Previous receipt of any study product (drug, vaccine, biological product or device) within 6 months before Study Day 0, or plan to participate in any other clinical study during this study period; 12. Females who are pregnant or with urine pregnancy test positive. |
Country | Name | City | State |
---|---|---|---|
China | Center for Disease Control and Prevention (CDC) | Kunming | Yunnan |
Lead Sponsor | Collaborator |
---|---|
Genrix (Shanghai) Biopharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the Geometric mean RVNA Concentration (accessd by Rapid Fluorescent Foci Inhibition Test(RIFFIT)) for GR1801 recipients is non-inferior to the Geometric mean RVNA Concentration for HRIG recipients on Study Day 7. | RVNA(Rabies Virus Neutralizing Antibodies) geometric mean concentration of GR1801 recipients and HRIG recipients in combination with rabies vaccines. | 7 days | |
Primary | To evaluate the percentage of subjects with RVNA concentration = 0.5 IU/mL on Study Day 14 in GR1801 recipients is non-inferior to the percentage of subjects with RVNA concentration = 0.5 IU/mL for HRIG. | The percentage of subjects with the RVNA geometric mean concentration = 0.5 IU/mL in GR1801 recipients and HRIG recipients in combination with rabies vaccines. | 14 days | |
Primary | To evaluate the rabies post-exposure protection rate for GR1801 recipients is non-inferior to the protection rate for HRIG recipients on Study Day 365. | The percentage of subjects with no case of rabies death in GR1801 recipients and HRIG recipients in combination with rabies vaccines. | 365 days | |
Secondary | To evaluate the rabies post-exposure morbidity of GR1801 compared to HRIG within 90 days and 365 days after administration. | The percentage of subjects with probable or confirmed cases of rabies. | 365 days | |
Secondary | To evaluate the rabies post-exposure mortality of GR1801 compared to HRIG within 90 days and 365 days after administration. | The percentage of subjects with cases of rabies death. | 365 days | |
Secondary | To evaluate the rabies post-exposure survival rate of GR1801 compared to HRIG within 90 days and 365 days after administration. | The percentage of subjects with rabies-free survival. | 365 days | |
Secondary | To evaluate the Geometric mean RVNA Concentration of GR1801 compared to HRIG within 1,3,5,14,42,90 and 365 days after administration. | RVNA geometric mean concentration. | 365 days | |
Secondary | To evaluate the percentage of subjects with RVNA concentration = 0.5 IU/mL of GR1801 compared to HRIG within 1,3,5,7,42,90 and 365 days after administration. | The percentage of subjects with RVNA geometric mean concentration = 0.5 IU/mL. | 365 days | |
Secondary | To evaluate the detection rate of RVNA concentration of GR1801 compared to HRIG within 1,3,5,7,14,42,90 and 365 days after administration. | The percentage of subjects whose RVNA geometric mean concentration are below the quantization limit. | 365 days | |
Secondary | To evaluate the safety of GR1801 compared to HRIG within 365 days. | Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0 | 365 days | |
Secondary | To evaluate the peak plasma concentration(Cmax) of GR1801 within 365 days. | The peak plasma concentration of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis. | 365 days | |
Secondary | To evaluate the Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 within 365 days. | The Area under the plasma concentration versus time curve (AUC0-last,AUC0-inf) of GR1801 will be estimated at D3,D7,D14 and D42,using non compartmental analysis. | 365 days | |
Secondary | To evaluate the immunogenicity of GR1801 within 365 days. | To assess the anti-drug-antibodies (ADA) and neutralizing antibodies (NAb) of GR1801. | 365 days |
Status | Clinical Trial | Phase | |
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Completed |
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