Rabies
Conditions
Interventions
Experimental group:NM57+ human rabies vaccine
Control group:HRIG+ human rabies vaccine
Sponsors
Yunnan Center for Diseases Control and Prevention
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: 1. Under the age of 18, legal identification can be provided; 2. Grade III rabies virus exposure and <24 hours; 3. The legal guardians of the subjects voluntarily agree to participate in the research and sign the informed consent form, among which: subjects under the age of 8 should fully respect their opinions and sign the informed consent form by the legal guardian; subjects aged 8-17, the legal guardian signs the informed consent form, and the subjects sign the informed consent form for underage subjects; 4. The subject and/or the subject's legal guardian has the ability to understand the research procedures and participate in all planned follow-up visits with the subject; 5. Axillary temperature <37.0 degree C; 6. Subjects who have menarche, agree to take a urine pregnancy test, and the urine pregnancy test result is negative, not breastfeeding, and has no pregnancy plan within 6 months.
Exclusion criteria
Exclusion criteria: 1. Previously used rabies vaccine or rabies immunoglobulin; 2. Have used any specific or non-specific immunoglobulin or antiserum products within 6 months, or plan to use them during the study; 3. A history of being bitten by a rabies virus-susceptible animal within 6 months; 4. The wound has been sutured after exposure to grade III rabies virus; 5. Suspected symptoms and/or signs of rabies appear; 6. There is a history of severe allergies to vaccines/drugs/food in the past, and the severity reaches level 3 or above of the 2019 grading standard; 7. Those who are known to be allergic to any ingredients contained in the investigational drug/vaccine; 8. Within 2 weeks before the first administration, according to the clinical judgment of the investigator, the subject has clinically significant acute disease or acute exacerbation of chronic disease or infectious disease; 9. Suffering from congenital diseases or defects; 10. After inquiring about the medical history, it was found that the medical history of the heart, liver, kidney, blood, digestive tract, nervous system, mental abnormality and metabolic abnormality, etc., was judged by the investigator to affect the research evaluation; 11. Upon inquiry, the subject has abnormal immune function or suffers from autoimmune disease; 12. Upon inquiry, receive systemic immunosuppressive therapy within 3 months before enrollment; 13. Glucocorticoid injection or oral administration within 3 days before the injection of the investigational drug; 14. Those with a history of thrombocytopenia or other coagulation disorders, which may cause intramuscular injection contraindications; 15. Those with a history of convulsions, epilepsy, mental and nervous system, or a family history of epilepsy; 16. Use of other vaccines within 14 days before the injection of the investigational drug/vaccine; 17. Have used any investigational or unregistered product other than the investigational product within 14 days before the injection of the investigational drug/vaccine, or plan to use it during the study; 18. Any other circumstances that the investigator believes may affect the evaluation of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| neutralizing antibody activity; | — |
Countries
China
Contacts
Public ContactZheng Yan
Yunnan Center for Disease Control and Prevention
Outcome results
None listed