herpes zoster prophylaxis
Conditions
Interventions
Vaccine group:vaccinate two doses of recombinant herpes zoster vaccine 30 days apart (Day 0, Day 30)
placebo group:vaccinate two doses of placebo 30 days apart (Day 0, Day 30)
Sponsors
Jiangsu Provincial Centre for Disease Prevention and Control
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Males and females able to provide legal identity certificate, aged = 40 years inclusive at the time of signing the ICF; 2) Able to understand the study procedures, voluntarily agree to participate in the study, and sign the ICF; 3) Female subjects are not pregnant or lactating. Female subjects with childbearing potential should take reliable contraceptive measures, and have no pregnancy and fertility plan within 7 months; 4) Axillary temperature = 37.0? on the day of enrollment; 5) Able to attend all scheduled follow-up visits and able to comply with protocol requirements;
Exclusion criteria
Exclusion criteria: 1) Subjects who have had herpes zoster within the previous 5 years; 2) Previous vaccination against varicella or shingles (including use of a registered product or participation in a clinical trial of varicella or shingles vaccine); 3) Hypersensitivity to any of the components of the test vaccine: or prior hypersensitivity to any recombinant vaccine of CHO cell origin [e.g., recombinant hepatitis B vaccine (CHO cell)], polysorbate, etc.; or prior history of severe allergy* to any of the vaccinations; *Severe allergies: anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction), severe urticaria. 4) Developed immunodeficiency diseases (congenital or acquired immunodeficiency diseases, human immunodeficiency virus infection) or received immunosuppressive/cytotoxic treatments (cancer chemotherapy, organ transplantation, or treatment planned during a clinical trial in the 6 months prior to vaccination); 5) Receiving immunosuppressive therapy (e.g., long-term systemic glucocorticoid application for =14 days at a dose of =2 mg/kg/day or =20 mg/day of prednisone or prednisone-equivalent dose) within 3 months prior to vaccination or within 1 month after the planned full course of immunization; 6) Received an inactivated or recombinant vaccine or mRNA vaccine within 14 days or any live attenuated vaccine within 28 days prior to vaccination; 7) Subjects who are suffering from an acute illness or are in the acute exacerbation phase of a chronic disease within 3 days prior to vaccination; 8) History of asplenia or functional asplenia, and asplenia or splenectomy due to any condition; 9) Treatment with blood products or globulins within 3 months prior to enrollment, or planned use of such products within 2 months of vaccination; 10) Participating in other clinical studies of investigational or un-registered products (drugs, vaccines or devices, etc.), or planning to participate in other clinical studies before the end of this clinical study; 11) Significant underlying medical conditions that, in the opinion of the investigator, may prevent completion of the trial (e.g., life-threatening disease that may limit survival to less than 4 years) or any other conditio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of herpes zoster at the end of the study; | — |
Secondary
| Measure | Time frame |
|---|---|
| gE antibody;safety profile; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed