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

Inclusion Criteria:

1. A male or female aged 50 to 70 years inclusive at screening.

2. Written informed consent obtained from the subject before any assessment isperformed.

3. Subjects who the investigator believes that they can and will comply with therequirements of the protocol. (e.g., complete the diary cards, and completefollow-up visits).

4. Subjects must have a Body Mass Index (BMI) between ≥18.0 and ≤35.0 kg/m^2 atscreening.

5. Female subjects who are not pregnant or lactating. Female subjects with childbearingpotential and their partners should use highly effective, medically accepteddouble-barrier contraception and will not have pregnancy and fertility plan untilstudy completion.

• Female subjects of childbearing potential are defined as sexually mature women:

1. have not undergone hysterectomy, bilateral salpingectomy, and bilateraloophorectomy; 2) have had natural menses at any time in the preceding 12consecutive months (without an alternative medical cause).

• Highly effective double-barrier contraception is defined as use of a condom ANDone of the following: Birth control pills (The Pill), Depot or injectable birthcontrol, Intrauterine device (IUD), Birth Control Patch (e.g., Ortho Evra),NuvaRing®, Implantable contraception (e.g., Implanon).

6. Males participating in this study must agree to use highly effective, medicallyaccepted double-barrier contraception (as described above) and refrain from donatingsperm until study completion.

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 HZvaccination during the study (including an investigational or non-registeredvaccine), except for the investigational vaccine.

4. Received a live attenuated vaccine within 28 days before vaccination or receivedother vaccines within 14 days before vaccination.

5. Received any immunoglobulins or blood/plasma products within 3 months prior tovaccination.

6. Individuals with the following diseases: 1）Any acute disease or acute attack ofchronic diseases or using antipyretic, analgesic or anti-allergic drugs (e.g.,acetaminophen, ibuprofen, aspirin, loratadine, cetirizine, etc.) within 3 days priorto enrolment; 2）Allergies to any component of the investigational vaccine; 3）Subjecthas any clinically significant history of allergic conditions to other vaccines. 4）History of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) orpsychiatric disorders (bipolar disorder, schizophrenia, etc.) that may increase therisk associated with study participation or investigational product administrationor may interfere with the interpretation of study results and, in the judgment ofthe investigator, would make the participant inappropriate for entry into thisstudy; 5）Asplenia, or functional asplenia; 6）Congenital or acquired immunodeficiencyor autoimmune disease; 7）Chronic administration (≥14 consecutive days) ofglucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) orother immunosuppressive agents within the past 3 months, with the exception ofinhaled or topical steroids, or short-term use (<14 consecutive days) of oralcorticosteroids; 8）Has severe cardiovascular diseases (cardiopulmonary disease,pulmonary edema), severe hepatic or renal diseases, and diabetes complications thatmay increase the risk associated with study participation or investigational productadministration or may interfere with the interpretation of study results and, in thejudgment of the investigator, would make the participant inappropriate for entryinto this study; 9）History of thrombocytopenia or other coagulation disorders whichmay be contraindications for an IM; 10）Severe hypertension uncontrolled bymedication 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 conditionand/or tattoo that may interfere with the evaluation of safety at the injectionsite.

7. Clinically significant laboratory abnormalities determined by the investigator priorto vaccination.

8. A positive urine drug test or alcohol breath test or a history of drug or alcoholabuse in the past 1 years.

9. Recent participation in another clinical trial, with receipt of the investigationaldrug/vaccine within 30 days prior to screening. Current participation or thoseplanning to participate in another clinical trial during the study.

10. Other conditions that may impact the subject's safety or influence the assessment ofvaccine response, as determined by the investigator.