Immunogenicity and Safety Assessment of Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried

Exclusion Criteria

• •1. History of injection with rabies vaccine and specific passive immune preparations, or history of dog or other mammal bites/scratches (Category II exposure or above) within the past year;
• •2. History of severe allergies requiring medical intervention from previous vaccinations; other severe allergies, such as allergic shock, angioneurotic edema, allergic purpura, local allergic necrotic reaction (Arthus reaction), severe urticaria, and angioneurotic edema;
• •3. Pyrexia (axillary temperature \> 38.5°C) within 3 days before the first dose vaccination; suffering from acute or chronic infectious diseases (active tuberculosis, viral hepatitis) or in the acute exacerbation phase of any chronic disease;
• •4. Having received blood/blood-related products or immunoglobulins within 3 months before the first dose vaccination; or planning to use such products within 1 month after the last dose vaccination;
• •5. Having received live attenuated vaccine within 14 days or any vaccine within 7 days before the first dose vaccination;
• •6. Any condition (e.g., splenectomy) leading to asplenia or functional asplenia;
• •7. Diagnosed with congenital or acquired immunodeficiency (HIV), or received immunosuppressant therapy within 3 months (e.g., long-term systemic glucocorticoid use ≥ 14 days, dose ≥ 2 mg/kg/day or ≥ 20 mg/day prednisone or equivalent);
• •8. Severe congenital anomaly, autoimmune disease, genetic disease; severe heart disorder, kidney disease, diabetes, or other severe chronic disease;
• •9. History of convulsion, epilepsy, or psychotic disorder;
• •10. Contraindications for intramuscular injection (e.g., diagnosed thrombocytopenia, any coagulopathy, or anticoagulant therapy);
• •11. Hypertension unable to be controlled with drugs, such as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg during physical examination before enrollment (for adults aged 18 and above);
• •12. Currently participating in a clinical study of another investigational or unregistered product (drug or vaccine) or planning to participate in other clinical studies before the end of this clinical study;
• •13. Any condition of the volunteer that may interfere with the assessment of the study purpose as deemed by the investigator.