Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older

Inclusion Criteria:

• Male or female participants aged 40 years or older at the time of enrollment.

• Voluntarily agrees to participate in the trial, fully understands, and signs theinformed consent form.

• Able to attend all scheduled follow-ups and comply with the clinical trial protocolrequirements to complete the trial.

• Female participants must meet the following criteria:1)Surgically sterilized orpostmenopausal for ≥2 years, or women of childbearing potential (not menopausal ormenopausal <2 years) with a negative pregnancy test and willing to use effectivephysical contraception (e.g., condoms, intrauterine device) from enrollment until 6months after full immunization. 2)Agree not to breastfeed from enrollment until 6months after full immunization.

• Axillary temperature ≤37.0°C.

Exclusion Criteria:

a Exclusion criteria for the first dose:

• A history of herpes zoster.

• A history of varicella or herpes zoster vaccination.

• Close contact with a varicella/herpes zoster patient within the past year.

• Received immunoglobulin and/or any blood products within 3 months beforevaccination.

• Received immunosuppressive treatment within 3 months prior to vaccination (e.g.,systemic corticosteroids for ≥14 days, at a dose ≥2 mg/kg/day or ≥20 mg/day ofprednisone, or an equivalent dose of prednisone) (excluding inhaled,intra-articular, and topical steroids).

• A history of severe allergic reactions to any vaccine or medication (e.g.,anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenicpurpura, local allergic necrosis reactions, severe urticaria, etc.), or a familyhistory of severe allergies.

• Immunocompromised or diagnosed with congenital or acquired immune deficiencydiseases, or infected with Human Immunodeficiency Virus (HIV).

• A history of seizures, epilepsy, encephalopathy (such as congenital brainmalformation, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction [except for infarction without sequelae or lacunar infarction], brain infections, orbrain damage caused by chemical drug poisoning), or psychiatric disorders, or afamily history of psychiatric disorders; or other serious neurological diseases.

• Inadequate time interval between vaccination and other vaccines (e.g., inactivatedor recombinant subunit vaccines within 14 days prior to vaccination, live attenuatedvaccines, viral vector vaccines, or mRNA vaccines within 28 days prior tovaccination).

• Acute illness or an acute exacerbation of a chronic disease within 3 days prior tovaccination, or use of antipyretic, analgesic, or antihistamine medications within 3days prior to vaccination.

• Suffering from severe infectious skin diseases.

• Ongoing or long-term alcohol and/or drug abuse history (Note: for the past threemonths, males drinking more than 14 standard drinks per week, females more than 7standard drinks per week. One standard drink contains 14g of alcohol, equivalent to 360mL of beer, 45mL of liquor at 40% alcohol, or 150mL of wine. Drug abuse refers tothe repeated or excessive use of drugs with dependence potential unrelated torecognized medical needs, for non-medical purposes).

• A history of thrombocytopenia or other coagulation disorders that may contraindicateintramuscular injection.

• Severe liver or kidney disease, complications from diabetes, severe cardiovasculardiseases, or uncontrolled hypertension despite medication.

• Asplenia or functional asplenia, or any condition leading to splenectomy.

• Abnormal laboratory test results before the first dose, deemed clinicallysignificant by the investigator (only applicable to Phase I).

• Currently participating in other experimental or unregistered clinical trials forproducts (drugs, vaccines, or devices), or planning to participate in anotherclinical trial before the end of this trial.

• A history of hematologic or lymphatic system diseases, such as unexplainedlymphadenopathy or hematolymphatic lymphoma.

• A history of diagnosed potential immune-mediated diseases, autoimmune diseases, orGuillain-Barré syndrome.

• Any other condition deemed by the investigator to be unsuitable for participation inthis clinical trial.

a Exclusion criteria for the second dose:

• Positive urine pregnancy test.

• Grade 4 adverse events related to vaccination.

• Severe allergic reactions occurring after vaccination.

• New findings or newly occurring conditions that meet the exclusion criteria afterthe first dose, with the investigator determining whether to terminate the trialvaccine administration.

• Other situations assessed by the investigator as requiring termination ofvaccination.