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The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-Dose Vaccine Group | Experimental |
| |
| High-Dose Vaccine Group | Experimental |
| |
| Placebo Group | Placebo Comparator |
| |
| Shingrix® Group | Active Comparator |
| |
| Ganwei® Group | Active Comparator | Herpes zoster vaccine, live; Changchun BCHT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose | Biological | Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart; |
| Measure | Description | Time Frame |
|---|---|---|
| phase 1: Incidence and intensity of solicited adverse events (AEs) | within 14 days after each vaccination | |
| phase 1: Incidence and intensity of unsolicited AEs | within 30 days after each vaccination | |
| phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody | at 30 days after full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody | at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination | |
| phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongyang Gao, Doctor | Contact | +86-010-58628288-9137 | dongyang_gao@sinocelltech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dazhu CDC | Dazhou | Sichuan | 635100 | China |
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| Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose | Biological | Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart; |
|
| Placebo control: Saline | Biological | The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart; |
|
| Shingrix® | Biological | Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart |
|
| Ganwei® | Biological | Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60; |
|
| at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination |
| phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs) | during the study (from the first vaccination to 12 months after full vaccination) |
| phase 1: Incidence and intensity of abnormal laboratory tests indicators | 3 days after each vaccination |
| phase 2: GMI of antigen-specific antibody | at 30 days after full vaccination |
| phase 2: GMC, GMI, and seroconversion rate of antigen-specific antibody | before the second vaccination, and at 6 months, 12 months and 24 months after full vaccination |
| phase 2: GMT/GMC, GMI, and seroconversion rate of VZV-specific antibody | before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination |
| phase 2: Frequencies and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by ICS | before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination |
| phase 2: Incidence and intensity of solicited AEs | within 14 days after each vaccination |
| phase 2: Incidence and intensity of unsolicited AEs | within 30 days after each vaccination |
| phase 2: Incidence of SAEs and AESIs | from the first vaccination to 12 months after full vaccination |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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