Varicella-Zoster
Conditions
Interventions
Investigational Vaccine:to receive the experimental vaccine
Positive Control Vaccine:to receive the positive control vaccine
Negative Control:to be administered the negative control (normal saline)
Adjuvant Control:to eceive the adjuvant-only control
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy individuals aged 40 years and above, including both males and females, with a balanced distribution as much as possible; 2. Participants voluntarily agree to take part in the study, sign the informed consent form, are able to provide valid identification, and understand and comply with the trial protocol requirements; 3. Women of childbearing potential must have used effective contraception within the 2 weeks prior to enrollment and have a negative pregnancy test result before vaccination. All male and female participants of childbearing potential voluntarily agree to practice effective contraception from the time of signing the informed consent until the end of the study (effective contraceptive methods include: oral contraceptives (excluding emergency contraception), injectable or implantable contraceptives, sustained-release topical contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.).
Exclusion criteria
Exclusion criteria: 1. History of previous vaccination with any herpes zoster or varicella vaccine (including marketed or investigational vaccines, or childhood varicella vaccination); 2. Known allergy to any component of the investigational vaccine, or a history of anaphylaxis or other severe adverse reactions to previous vaccinations; 3. History of herpes zoster, varicella within the past year, or close contact (co-residing, studying, or working) with individuals with varicella/herpes zoster within the past month; 4. Axillary temperature >= 37.3°C on the day of enrollment; 5. Abnormal blood pressure during screening prior to enrollment (systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg); 6. Administration of subunit and/or inactivated vaccines within 14 days prior to enrollment, or live attenuated vaccines within 28 days prior to enrollment; 7. Use of antipyretics, analgesics, or anti-allergy medications within 24 hours prior to enrollment; 8. Receipt of blood or blood-derived products (including immunoglobulins) within 6 months prior to enrollment, or planned use within 1 month after completion of the vaccination series; 9. Clinically significant abnormalities in 12-lead electrocardiogram, physical examination, or protocol-specified laboratory tests (hematology, blood biochemistry, urinalysis) during screening prior to enrollment; 10. Current presence of severe infectious, purulent, or allergic skin diseases; 11. Any acute illness within 7 days prior to enrollment, or chronic disease in an active/acute phase; 12. History of congenital or acquired immunodeficiency or autoimmune disease; or long-term use (continuous use > 14 days) of glucocorticoids (dose >= 20 mg/day prednisone or equivalent) or other immunosuppressants within the past 6 months. The following are allowed: inhaled or topical steroids, or short-term use (course <= 14 days) of oral steroids; 13. Current active tuberculosis, active viral hepatitis, or other severe infectious diseases; 14. Current or history of convulsions, epilepsy, encephalopathy (e.g., brain tissue damage due to congenital maldevelopment, trauma, tumor, hemorrhage, infarction, infection, chemical intoxication), psychosis, other neurological disorders, or family history of psychosis; 15. Asplenia or functional asplenia; 16. Severe or uncontrolled conditions requiring hospitalization, affecting the cardiovascular, endocrine, hematologic, lymphatic, immune, hepatic, renal, respiratory, metabolic, or skeletal systems, or malignancy; 17. Contraindications to intramuscular injection or blood drawing, such as coagulation disorders, thrombotic or hemorrhagic diseases, or conditions requiring ongoing anticoagulant therapy; 18. Women who are breastfeeding, pregnant, or planning to become pregnant during the study period; 19. Previous or current participation in other clinical trials related to varicella/herpes zoster vaccines, or ongoing/planned participation in any other clinical trials during the study period; 20. Any condition identified by the investigator that may place the subject at unacceptable risk, prevent compliance with the protocol requirements, or interfere with the evaluation of the vaccine response;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious Adverse Event and Adverse Event of Special Interest;Adverse Event;Urinalysis;Complete Blood Count;Blood Chemistry; | — |
Secondary
| Measure | Time frame |
|---|---|
| gE Antibody;The percentage of gE-specific CD4+ T cells;The percentage of gE-specific CD8+ T cells;VZV-specific antibody levels; | — |
Countries
China
Contacts
Public ContactLei Wang
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed