A Phase I, the Study to Evaluate the Safety, Immunogenicity and Efficacy of YS-HBV-002

Exclusion Criteria

• •1. Pregnant or breastfeeding or intending to become pregnant within the projected duration of the trial
• •2. Transient elastography at screening revealing a FibroScan value of ≥ 9 kPa or a previous liver biopsy evidencing hepatic fibrosis at or within 24 months prior to vaccination
• •3. Patients with hepatitis caused by other etiologies
• •4. History of or manifestations of liver decompensation (e.g., Child-Pugh Class B or C, or ascites, gastrointestinal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, etc....)
• •5. Currently participating in or has participated in a study with an IP within 30 days preceding Day 0
• •6. Fever (axillary temperature ≥ 37.8 ℃)
• •7. Subjects with abnormal indicators of blood biochemistry and other routine blood tests deemed clinically significant by the investigator
• •8. History of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema, or allergic abdominal pain) or allergy to any of the components of YS-HBV-002
• •9. Any history of anaphylaxis or angioedema after any vaccination
• •10. Allergy to kanamycin and aminoglycosides
• •11. Past or family history of convulsion, epilepsy, encephalopathy, or mental illness
• •12. Diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases
• •13. History of coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disease)
• •14. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on the investigator's judgement
• •15. Vaccinated with live attenuated vaccine within 1 month, or other vaccine/non-COVID-19 vaccine within 14 days prior to vaccination
• •16. Receiving immunotherapy or inhibitor therapy (consistently oral or infusion for more than 14 days) within 3 months prior to vaccination
• •17. Received systemic immunosuppressants within 4 months prior to vaccination or anticipating the need for immunosuppressant at any time during participation in the study. Topical or inhaled treatment is allowed if not used within 14 days prior to vaccination
• •18. Have received antiviral therapy for chronic hepatitis but have stopped for less than 30 days or plan to take antiviral therapy during the study
• •19. Received blood products within 3 months before vaccine administration
• •20. History of alcohol or drug abuse within the past 2 years
• •21. Any condition that, in the opinion of the investigator, would pose a health risk to the patient if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results.