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Varicella-zoster virus (VZV) is a herpesvirus that causes two distinct clinical syndromes.Primary infection is manifested as varicella (chickenpox), whereas reactivation of latent VZV results in a localized eruption known as herpes zoster. Most people 40 years of age or older had evidence of previous VZV infection. This study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. The investigational vaccine is produced by Shanghai Institute of Biological Products Co., Ltd. The safety and immunogenicity of the zoster vaccine is evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zoster vaccine, Live | Experimental | live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose) |
|
| Varicella vaccine, Live | Active Comparator | live attenuated varicella-zoster virus vaccine (with live virus >=3.3 LgPFU per dose) |
|
| Placebo | Placebo Comparator | Placebo with no live virus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One shot of the zoster vaccine | Biological | One shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity in the group of live attenuated zoster vaccine |
| 0 days-6 months after the vaccination |
| VZV specific serum conversion rate | VZV specific serum conversion is defined as: if serum antibody titer before immunization was less than 1: 8, and antibody titer after immunization was ≥ 1: 8. Or the antibody titer before immunization was≥1:8, and the antibody titer after immunization≥4-fold increase. | 30 days after the vaccination |
| VZV specific serum geometric mean titre | For each group serum titre with FAMA test | 30 days after the vaccination |
| VZV specific serum geometric mean fold increase | For each group serum titre with FAMA test | 30 days after the vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Reactogenicity in the group of live attenuated varicella vaccine |
| 0 days-6 months after the vaccination |
| Reactogenicity in the group of placebo |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Provincial Center for Disease Control and Prevention | Zhaoge | Henan | 450016 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2018 | Aug 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| One shot of the varicella vaccine | Biological | One shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose) |
|
| one shot of placebo | Biological | one shot of placebo with no live virus |
|
|
| 0 days-6 months after the vaccination |
| The immunogenicity persistence of antibody titer | The antibody titer measured by FAMA postvaccination in day 90,180,360 | 90 days-360 days after vaccination |
| D007239 | Infections |