A Safety and Immunogenicity Trial of the Recombinant Zoster Vaccine （CHO Cell）, LYB004 in Adults Aged 50 to 70 Years

Exclusion Criteria

• •1. Tympanic temperature \> 37.5°C at screening.
• •2. History of HZ.
• •3. Previous vaccination against HZ or varicella. Planned administration of VZV or HZ vaccination during the study (including an investigational or non-registered vaccine), except for the investigational vaccine.
• •4. Received a live attenuated vaccine within 28 days before vaccination or received other vaccines within 14 days before vaccination.
• •5. Received any immunoglobulins or blood/plasma products within 3 months prior to vaccination.
• •6. Individuals with the following diseases: 1）Any acute disease or acute attack of chronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g., acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days prior to enrolment; 2）Allergies to any component of the investigational vaccine; 3）Subject has any clinically significant history of allergic conditions to other vaccines. 4）History of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders (bipolar disorder, schizophrenia, etc.) that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 5）Asplenia, or functional asplenia; 6）Congenital or acquired immunodeficiency or autoimmune disease; 7）Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (\<14 consecutive days) of oral corticosteroids; 8）Has severe cardiovascular diseases (cardiopulmonary disease, pulmonary edema), severe hepatic or renal diseases, and diabetes complications that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study; 9）History of thrombocytopenia or other coagulation disorders which may be contraindications for an IM; 10）Severe hypertension uncontrolled by medication with systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg; 11）Positive test for Hepatitis C virus (HCV), Hepatitis B surface antigen (HbsAg), Human immunodeficiency virus (HIV) at screening; 12）Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.
• •7. Clinically significant laboratory abnormalities determined by the investigator prior to vaccination.
• •8. A positive urine drug test or alcohol breath test or a history of drug or alcohol abuse in the past 1 years.
• •9. Recent participation in another clinical trial, with receipt of the investigational drug/vaccine within 30 days prior to screening. Current participation or those planning to participate in another clinical trial during the study.
• •10. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.