Rabies
Conditions
Interventions
Group 1:rhRIG(20IU/kg)+vaccine
Group 2:rhRIG(40IU/kg)+vaccine
Group 3:rhRIG(20IU/kg)+ Normal Saline
Group 4:HRIG(20IU/kg)+vaccine
Control group 1:vehicle+vaccine
Control group 2:vehicle+Normal Saline
Sponsors
Beijing You'an Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy adults aged 18-45 years, who have informed consent and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. It is considered that the requirements of the clinical trial program cannot be complied with; 2. Have bad habits of alcoholism; 3. Positive pregnancy test results; 4. Lactating women; 5. Questioned medical history, physical examination, heart, liver, kidney, blood, digestive tract, nervous system, mental disorders and metabolic abnormalities; 6. Have a history of drug allergy, especially allergic to vaccines, serum, immunoglobulins, antibodies and other biological agents; 7. Physical examination showed blood pressure, heart rate, electrocardiogram, respiratory status, liver, kidney function and abnormal blood; 8. The weight exceeds the range of ±10% of the standard weight; 9. Those who have been vaccinated with rabies (positive serum antibody test results); 10. Vaccination products such as immunoglobulins are inoculated within one month before the test; 11. Any medication used within two weeks; 12. Allergic to any component of the research product; 13. Known immunological function damage; 14. Known active infections (such as hepatitis B, hepatitis C, HIV infected); 15. Any situation that the investigator believes may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibody neutralization activity;Antibody concentration;Human anti-human antibody concentration; | — |
Countries
China
Contacts
Public ContactMeixia Wang
Outcome results
None listed