Study to Evaluate GR1801's Efficacy and Safety
Rabies Post-exposure Prophylaxis
About this trial
This is an interventional prevention trial for Rabies Post-exposure Prophylaxis focused on measuring Rabies, Rabies virus neutralizing antibodies, Post-exposure prophylaxis
Eligibility Criteria
Inclusion Criteria: 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; WHO Category III rabies exposure; Those who have an armpit temperature ≤ 37.0 °C; Completed written informed consent process, signed the informed consent forms and Agreed to complete all follow-ups. Exclusion Criteria: WHO Category III rabies exposure but received wound suture treatment; WHO Category III rabies exposure over 72 hours; Previous receipt of rabies vaccination or rabies passive immunization; History of bitten by animals such as dogs, cats, bats etc. within the 6 months before the Study Day 0; History of any severe allergy for vaccination; Had fever (armpit temperature ≥ 38.5 °C) or received any antipyretic, analgesic or anti-allergic drug within 3 days before Study Day 0; History of severe autoimmune diseases; History of any severe neurological disease; History of receiving any immunoglobulin or vaccine within 30 days before Study Day 0, or plan to use any such product during the study; History of addiction to any narcotic, alcohol or drugs; 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; Females who are pregnant or with urine pregnancy test positive.
Sites / Locations
- Center for Disease Control and Prevention (CDC)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental Group: GR1801+Rabies vaccine(CHENGDA PHARMACEUTICALS)
Control Group:HRIG(BOYA-BIO)+Rabies vaccine(CHENGDA PHARMACEUTICALS)
GR1801 injections are administered by wound infiltration injection or by intramuscular injection.GR1801 injections are a bispecific monoclonal antibody that exhibit a wide spectrum of activity against various wild-type rabies strains in vitro. Dosage form:2mg/1mL/vial, liquid, Dosage: 0.05mg/kg of GR1801 Frequency/duration: at Day 0. Rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28.
HRIG is administered by wound infiltration injection or by intramuscular injection. Dosage form: 200 IU/2mL/vial, liquid, Dosage: 20 IU/kg, Frequency/duration: at Day 0. Rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, 0.5 mL after reconstitution, Frequency/duration: at Day 0, 3, 7, 14, 28.