Prevention of herpes zoster
Conditions
Interventions
Recombinant varicella-zoster vaccine (CHO cells) (low-dose adjuvant) Group:ecombinant varicella-zoster virus glycoprotein E (gE) 50 µg + low-dose adjuvant system
Recombinant varicella-zoster vaccine (CHO cells) (high-dose adjuvant) Group:Recombinant varicella-zoster virus glycoprotein E (gE) 50 µg + high-dose adjuvant system
Recombinant Herpes Zoster Vaccine (CHO Cell) with Composite Adjuvant System (Low Dose) Group:Low-dose adjuvant system
Recombinant Herpes Zoster Vaccine (CHO Cell) with Composite Adjuvant System (High Dose) Group:High-dose adjuvant system
Placebo Group:Sodium chloride injection
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female participants aged 40 years or older. 2. Ability to fully understand and voluntarily sign the informed consent form. 3. Clinical assessment by investigators, based on medical history inquiry and relevant physical examinations, confirming eligibility for trial vaccine administration. 4. Compliance with the clinical trial protocol requirements for completing the trial. 5. Axillary body temperature =2 years, or women of childbearing age (non-menopausal or postmenopausal for <2 years) with negative pregnancy test results, and willing to adopt effective physical contraception (e.g., condoms) from the date of signing the informed consent form until at least 3 months after the last trial vaccine administration; contraceptive pills are not permitted. Consent to abstain from breastfeeding from the date of signing the informed consent form until at least 3 months after the last trial vaccine administration. 7. Male participants must meet the following criteria: if not undergoing sterilization surgery and engaging in sexual activity that may result in pregnancy, agree to adopt effective physical contraception (e.g., condoms) from the date of signing the informed consent form until at least 3 months after completing the full immunization schedule.
Exclusion criteria
Exclusion criteria: 1. History of suspected or confirmed herpes zoster; 2. History of varicella or herpes zoster vaccination; 3. History of varicella/herpes zoster exposure within 1 year prior to enrollment; 4. Allergy to any component of the trial vaccine or history of severe allergic reactions to any vaccine, such as urticaria, dyspnea, or angioedema; 5. Received immunosuppressive therapy (e.g., long-term systemic glucocorticoids >=14 days, dose >=2 mg/kg/day or >=20 mg/day prednisone or equivalent) within 3 months prior to vaccination (excluding inhaled, intra-articular, and topical corticosteroids); received whole blood or blood products within 3 months prior to vaccination or planned for use during the trial; 6. Received any vaccine within 14 days prior to vaccination or received a live attenuated vaccine within 28 days prior to vaccination; 7. Suffered from an acute illness within 3 days prior to vaccination or was in the acute phase of a chronic disease; 8. Has a history of seizures, epilepsy, encephalopathy (e.g., congenital brain dysplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, brain infections, or neurological tissue damage caused by chemical drug poisoning) or psychiatric disorders, or a family history of psychiatric disorders; 9. Is a splenectomy or functional splenectomy, or has undergone splenectomy for any reason; 10. Has primary or secondary immunodeficiency or has been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune diseases; 11. Suffers from severe cardiovascular disease (pulmonary heart disease, pulmonary edema), severe liver or kidney disease, or diabetes with complications; 12. Has a history of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection; 13. Has uncontrolled hypertension (pre-vaccination physical examination showing systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 14. Had a fever (axillary temperature >=37.3°C) within 3 days prior to enrollment, or had an acute illness requiring systemic antibiotic or antiviral therapy or was in the acute phase of a chronic infection within 7 days prior; 15. Had abnormal laboratory tests or electrocardiogram (ECG) findings prior to vaccination that were clinically significant as determined by a clinician; 16. Were lactating, pregnant, or planned to conceive within at least 3 months from the date of signing the informed consent form until the last trial vaccine administration, or were male participants planning to conceive their partner within at least 3 months from the start of the trial until the last trial vaccine administration; 17. Had a history of chronic alcohol abuse or substance abuse; 18. Had participated in other drug or vaccine clinical trials within 30 days prior to the first trial vaccine administration or planned to participate in such trials during the study; 19. The investigator determined that the participant had other conditions unsuitable for participation in the trial, including but not limited to inability to attend follow-up visits as per the trial protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event rates at 30 minutes after each dose, 0-14 days, and 0-30 days post-vaccination.;Incidence of SAEs and AESIs from the first dose of vaccination to 12 months after the second dose;The incidence of clinically significant abnormalities in complete blood count (CBC), blood biochemistry, coagulation function, urinalysis, and electrocardiogram (ECG) on day 4 after each vaccine dose compared to the pre-dose period.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum antibody seroconversion rate, geometric mean titer (GMT), and geometric mean increase (GMI) of anti-VZV antigen before each dose, on day 30 after each dose, 6 months after the second dose, and 12 months after the second dose;Serum antibody seroconversion rate, GMC, and GMI against gE antigen before each dose of vaccination, on day 30 after each dose, 6 months after the second dose, and 12 months after the second dose;Vaccine: The proportion of CD4+ T cells secreting at least two gE antigen-specific cytokines (IFN-?, IL-2, TNF-a, CD40L) and the cellular immune response rate before each dose, on day 30 after each dose, 6 months after the second dose, and 12 months after the second dose.; | — |
Countries
China
Contacts
Public ContactYeqing Tong
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed