Zoster prophylaxis
Conditions
Interventions
Experimental vaccine group:Recombinant herpes zoster vaccine was administered at D0-D30
Control vaccine group:Recombinant herpes zoster vaccine was administered at D0-D60
Sponsors
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1 Age 50 and above on the day of enrollment, regardless of gender, can provide legal identification 2. Be able to understand the test procedure, voluntarily agree to participate in the test, and sign the informed consent 3 Female subjects are not pregnant or breastfeeding, and female subjects of childbearing age should take reliable contraceptive measures and have no pregnancy or birth plan within 8 months 4. Armpit body temperature =37.0? on the day of entry 5 Be able to participate in all planned follow-up visits and be able to comply with program requirements
Exclusion criteria
Exclusion criteria: 1 People who have had shingles within the past 5 years 2 Previous vaccination with varicella vaccine or shingles vaccine (including use of registered products or participation in clinical trials of varicella vaccine or shingles vaccine) 3 Allergic to test vaccine components: or allergic to any recombinant vaccine derived from CHO cells (such as recombinant hepatitis B vaccine (CHO cells)), polysorbate, etc.; Or have a history of severe allergy * to any previous vaccination; 4 Have an immunodeficiency disease (e.g., congenital or acquired immunodeficiency disease, human immunodeficiency virus infection, etc.) or receive immunosuppressive/cytotoxic therapy (cancer chemotherapy within 6 months prior to vaccination, organ transplant, or planned treatment during clinical trials) 5 Patients receiving immunosuppressive therapy (e.g., long-term systemic glucocorticoids =14 days, doses =2mg/kg/ day or =20mg/ day of prednisone or equivalent) within 3 months before vaccination or 1 month after scheduled full immunization 6 Received inactivated or recombinant vaccine or mRNA vaccine within 14 days prior to vaccination, or received any live attenuated vaccine within 28 days 7 Acute illness or acute onset of chronic disease in the 3 days prior to vaccination 8 Absence of spleen or splenectomy 9 Received blood products or globulins within 3 months prior to enrollment, or planned to use such products within 2 months after vaccination 10 Are participating in other investigational or unregistered clinical trials for products (drugs, vaccines or devices, etc.), or plan to participate in other clinical trials before the end of this clinical trial 11 A major underlying disease (e.g., a life-threatening disease that may limit survival to less than 4 years) or any other condition that the investigators believe may prevent completion of the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Geometric mean concentration of anti-GE antibody;Positive rate of geometric mean concentration of anti-GE antibody;Geometric mean growth multiple of anti-GE antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of solicited adverse events at vaccination sites (local) and non-vaccination sites (systemic);Incidence of unsolicited AE;Incidence of AE;Special attention to adverse event rates;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactJingxin Li
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Outcome results
None listed