herpes zoster
Conditions
Interventions
Experimental Group:The experimental group received two doses of the vaccine according to the "0-30 days" schedule
Delayed control group:The subjects in delayed control group received two doses of the vaccine according to the "0-30 day" schedule on the 60th day
Sponsors
Wuxi Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age =50 years old on the day of enrollment, both sexes, and legal identification can be provided; (2) able to understand the trial procedures, voluntarily agree to participate in the trial, and sign the informed consent form; (3) Female subjects who are not pregnant, lactating, and of childbearing age should take reliable contraceptive measures, no pregnancy or family planning within 7 months; (4) Axillary temperature =37.0? on the day of enrollment; 5) be able to attend all scheduled follow-up visits and adhere to protocol requirements.
Exclusion criteria
Exclusion criteria: (1) Individuals who have developed shingles within the past 5 years; (2) Previously received varicella vaccine or shingles vaccine (including using registered products or participating in clinical trials of varicella vaccine or shingles vaccine); (3) Individuals who are allergic to the components of the experimental vaccine: those who have previously been allergic to any recombinant vaccine derived from CHO cells, such as recombinant hepatitis B vaccine (CHO cells), polysorbate, etc; Or those who have a history of severe allergies to vaccines in the past* Severe allergies: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), severe urticaria, etc. (4) Suffering from immunodeficiency diseases (such as congenital or acquired immunodeficiency diseases, human immunodeficiency virus infections, etc.) or receiving immunosuppressive/cytotoxic therapy (cancer chemotherapy, organ transplantation, or planned treatment during clinical trials within 6 months before vaccination); (5) Those who have received immunosuppressive therapy (such as long-term use of systemic corticosteroids for = 14 days, dose = 2mg/kg/day or = 20mg/day, prednisone or equivalent prednisone dose) within 3 months before vaccination or within 1 month after full immunization; (6) Received inactivated vaccine, recombinant vaccine or mRNA vaccine within 14 days before vaccination, or received any attenuated live vaccine within 28 days; (7) Individuals who have suffered from acute illness or are in the acute phase of chronic illness within 3 days prior to vaccination; (8) Individuals without spleen or undergoing splenectomy; (9) Received blood products or globulin therapy within 3 months before enrollment, or planned to use such products within 2 months after vaccination; (10) Currently participating in clinical trials of other investigational or unregistered products (drugs, vaccines, devices, etc.), or planning to participate in other clinical trials before the end of this clinical trial; (11) Researchers believe that major underlying diseases (such as life-threatening diseases that may limit survival to less than 4 years) or any other circumstances that may hinder the completion of the experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportions of immune cells and their subsets (dendritic cells, monocytes, NK cells, and macrophages);Differentially expressed genes of immune cell transcriptome and serum cytokines and pathway analysis after enrichment;The percentage of anti-GE protein specific CD4+ and CD8+ T cells secreting at least two cytokines (TNF-a, IFN-?, IL-2, CD40L) ;The proportion and distribution of various functional and activated adaptive immune cells and subtypes, including Tfh, Treg, Naive T cells, Tcm, Tem, Teff, etc;IgG binding antibody GMT and ADCC levels; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Center for Disease Control and Prevention (Jiangsu Academy of Preventive Medicine)
Outcome results
None listed