Safety and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Healthy Subjects Aged 18 Years and Above

Inclusion Criteria:

1. Permanent residents aged 18 years and above;

2. Subjects voluntarily agree to participate in the study and signed an informedconsent;

3. Be able to participate in all scheduled visits and comply with the protocolrequirements.

Exclusion Criteria:

1. Axillary temperature>37.0℃;

2. History of herpes zoster within 5 years before vaccination;

3. Prior vaccination with chickenpox vaccine or herpes zoster vaccine;

4. Female participant who is pregnant ( urine pregnancy test was positive) orbreastfeeding, or has pregnancy plans within 1 year after the last vaccination;

5. Receipt of live vaccine within 28 days, or any other vaccine within 14 days prior tovaccination;

6. Receipt of immunoglobulin or intravenous immunoglobulin within 3 months beforevaccination;

7. Acute diseases or acute exacerbation of chronic disease within 3 days beforevaccination;

8. A known allergy to any components of the study vaccine (especially allergic toaminoglycoside antibiotics), or history of severe allergy to any previousvaccination;

9. History of convulsions, epilepsy, encephalopathy (such as congenital braindysplasia, brain trauma, brain tumor, cerebral hemorrhage, cerebral infarction,brain infection disease, nerve tissue damage caused by chemical drug poisoning,etc.) or mental illness and family history;

10. Asplenia or functional asplenia, or splenectomy caused by any condition;

11. Primary or secondary impairment of immune function or diagnosed congenital oracquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma,leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenilerheumatoid arthritis (JRA), inflammatory bowel disease or other autoimmune diseases;

12. Receipt of immunosuppressive therapy within 3 months before vaccination (such aslong-term use of systemic glucocorticoid ≥14 days, dose ≥2mg/kg/day or ≥20mg/dayprednisone or equivalent dose), but inhaled, intra-articular and topical steroidsare acceptable;

13. Severe cardiovascular disease(eg. Pulmonary heart disease, Pulmonary Edema); Severeliver or kidney disease; or diabetes with complication;

14. History of thrombocytopenia or other coagulation disorders, which may causeintramuscular injection contraindications;

15. Abnormal blood pressure during physical examination before vaccination (systolicpressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mmHg);

16. Abnormal and clinically significant laboratory test results as determined by theinvestigator before vaccination;

17. Current or history of alcohol and/or drug abuse;

18. Any condition that, in the opinion the investigator, may affect the safety of thesubject or the evaluation of the study results.