Clinical trial
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.
Name
GR1801-003
Description
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.
Trial arms
Trial start
2022-10-21
Estimated PCD
2023-09-06
Trial end
2024-07-01
Status
Recruiting
Phase
Early phase I
Treatment
GR1801
The injection solution GR1801 does not contain preservatives. The excipients include histidine/histidine hydrochloride (20mM), trehalose (90 mg/mL), disodium EDTA (0.372mg/mL) and polysorbate 80 (0.5 mg/mL). The pH value is 5.8 and each bottle contains 2mg of GR1801 protein. The packaging material is a borosilicate glass tube injection bottle (2mL) with a halogenated butyl rubber stopper for injection and an aluminum-plastic composite cap for antibiotic bottles.
Arms:
Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS)
Human Rabies Immunoglobulin(HRIG)
The HRIG is a Chinese licensed Human Rabies Immunoglobulin produced by BOYA-BIO, which are derived from human plasma, and then purified and filled in the injectable vial form.
Arms:
Control Group:HRIG（BOYA-BIO）+Rabies vaccine(CHENGDA PHARMACEUTICALS)
Rabies Vaccine
The Chinese licensed freeze-dried rabies vaccine produced by CHENGDA PHARMACEUTICALS for human use (Vero Cells) which is indicated for the rabies Post-exposure Prophylaxis (PEP) .
Arms:
Control Group:HRIG（BOYA-BIO）+Rabies vaccine(CHENGDA PHARMACEUTICALS), Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS)
Size
1200
Primary endpoint
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.
7 days
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.
14 days
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.
365 days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1200 patients aged 18 and above with WHO Category III rabies exposure should be enrolled as planned and randomly assigned to the GR1801 injection group and the HRIG group based on a ratio of 3: 1. The random stratification factors include time of exposure (within or beyond 24 hours), bite location (above or below the neck), and number of bites (1 or more).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'maskingDescription': 'double blind', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 1200, 'type': 'ESTIMATED'}}
Updated at
2023-09-21
1 organization
3 products
1 indication
Product
GR1801Indication
Rabies Post-exposure ProphylaxisProduct
Human Rabies ImmunoglobulinOrganization
Genrix (Shanghai) BiopharmaceuticalProduct
Rabies Vaccine