herpes zoster
Conditions
Interventions
(0, 2 months) Positive control group:Administer 0.5ml of positive control vaccine
(0,2 months) 50 µ g experimental vaccine group:Administer 50 µg of experimental vaccine
(0,2 months) 75 µ g experimental vaccine group:Administer 75 µg of experimental vaccine
(0,3 months) 50 µ g experimental vaccine group:Administer 50 µg of experimental vaccine
(0,3 months) 75 µ g experimental vaccine group:Administer 75 µg of experimental vaccine
(0,2 months) Negative control group:Administer 0.5ml negative control vaccine
Sponsors
Hubei Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
40 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Healthy individuals aged 40 and above, both male and female, striving for balance; 2. The participants voluntarily participate in the study, sign an informed consent form, and provide valid identification to understand and comply with the requirements of the trial protocol; 3. Women of childbearing age took effective contraceptive measures within 2 weeks before participating in this study, and the pregnancy test results before vaccination were negative. All male and female trial participants of childbearing age voluntarily agree to take effective contraceptive measures (including oral contraceptives (excluding emergency contraceptives), injectable or buried contraceptives, slow-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.) from the time of signing the informed consent form until 12 months after full vaccination.
Exclusion criteria
Exclusion criteria: 1. Previous history of receiving shingles vaccine or varicella vaccine (including marketed or unlisted vaccine administration, as well as childhood vaccination with varicella vaccine); 2. Known to be allergic to the experimental vaccine or its excipients, or have a history of allergic shock or other serious adverse reactions to other vaccines; 3. Individuals with a history of herpes zoster disease, a history of chickenpox in the past year, or a history of living, studying, or working with chickenpox/shingles patients within the past month; 4. On the day of enrollment, the axillary temperature was >= 37.3 ?; 5. Prior to enrollment, individuals with abnormal blood pressure during physical examination (systolic blood pressure = 140mmHg and/or diastolic blood pressure >= 90mmHg); 6. Within 14 days before enrollment, receive subunit vaccines and/or inactivated vaccines internally, or receive attenuated live vaccines within 28 days; 7. Have taken antipyretic, analgesic, or anti allergic drugs within 24 hours prior to enrollment; 8. Have received blood or blood related products, including immunoglobulin, within the first 6 months of enrollment; Or planned to use during the research period; 9. Currently suffering from various severe infectious, suppurative, and allergic skin diseases; 10. Suffering from any acute illness or in the acute phase of chronic illness within 7 days prior to enrollment; 11. History of congenital or acquired immunodeficiency or autoimmune disease, or long-term use (continuous use>14 days) of corticosteroids (dose >= 20mg/day prednisone or equivalent) or other immunosuppressants within the past 6 months, but the following situations are allowed to be included: inhalation or local use of topical steroids, or short-term use (course of treatment <= 14 days) of oral steroids; 12. Individuals currently suffering from serious infectious diseases such as active tuberculosis and active viral hepatitis; 13. Currently or previously suffering from seizures, epilepsy, encephalopathy (such as congenital brain hypoplasia, traumatic brain injury, brain tumor, cerebral hemorrhage, cerebral infarction, brain infection, chemical drug poisoning, etc.), mental illness or other neurological disorders, or having a family history of mental illness; 14. No spleen, or functional no spleen; 15. Serious or uncontrollable cardiovascular diseases, endocrine system diseases, blood and lymphatic system diseases, immune system diseases, liver and kidney diseases, respiratory system diseases, metabolic and skeletal system diseases, or malignant tumors that require hospitalization; 16. There are contraindications for intramuscular injection and blood drawing, such as coagulation dysfunction, thrombotic or hemorrhagic diseases, or the need for continuous use of anticoagulants; 17. Breastfeeding women or pregnant women, or women who plan to become pregnant within 12 months after full vaccination; 18. Individuals who have participated or are currently participating in other clinical trials related to varicella and shingles vaccines, as well as those who are currently or plan to participate in other clinical trials during the study period; 19. Researchers believe that the presence of any disease or condition among trial participants may put them at unacceptable risk; The experimental participants are unable to meet the requirements of the protocol; Interference with the evaluation of vaccine response;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean concentration of glycoprotein E antibody;Geometric growth factor of varicella zoster virus specific antibodies;Varicella zoster virus specific antibody like conversion rate;Geometric growth factor of glycoprotein E antibody;The positive rate of sugar protein E antibody;Positive conversion rate of glycoprotein E antibody;Geometric mean titers of varicella zoster virus specific antibodies;Positive rate of varicella zoster virus specific antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event;Pregnancy events;Incidence of serious adverse events;Pay special attention to the incidence of adverse events; | — |
Countries
China
Contacts
Public ContactLeiWang
Hubei Provincial Center for Disease Control and Prevention
Outcome results
None listed