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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. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.
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. The investigational vaccine of this study is produced by Changchun BCHT biotechnology Co. It's a live attenuated herpes zoster vaccine based on the production process of live attenuated chickenpox vaccine.This study plans to have 25000 adults aged 40 years or older and involves in a randomized, double-blind, placebo-controlled trial . The primary outcome is to evaluate the efficacy of the vaccine against herpes zoster 30 days after vaccination and the safety of the vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attenuated Zoster Vaccine, Live | Experimental | One shot of the vaccine (with live viruses titer >=4.3 LgPFU per dose) |
|
| Placebo | Placebo Comparator | one shot of placebo with no live virus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| live attenuated zoster vaccine | Biological | subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of herpes zoster 30 days to 13 months after vaccination | The incidence of herpes zoster diagnosed in participants 30 days to 13 months after vaccination | 30 days - 13 months after the vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of herpes zoster after vaccination | The incidence of herpes zoster diagnosed in participants after vaccination. | 0 day-13 months after the vaccination |
| The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of postherpetic neuralgia (PHN)30 days to 13 months after vaccination | The incidence of postherpetic neuralgia (PHN)diagnosed 30 days to 13 months after vaccination | 30 days -13 months after the vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fengcai Zhu, Master | LocationJiangsu Province Center for Disease Control and Prevention | Principal Investigator |
| Zhiping Chen | Zhejiang Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Center for Disease Control and Prevention | Nanjing | Jiangsu | 210009 | China | ||
| Zhejiang Provincial Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37781954 | Derived | de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. |
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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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| placebo |
| Biological |
subcutaneous injection |
|
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days to 13 months after vaccination. |
| 30 days- 13 months after the vaccination |
| Occurrence of solicited adverse reactions after the vaccination | Occurrence of solicited adverse reactions within 14 days after the vaccination. | within 14 days after the vaccination |
| Occurrence of adverse reactions after the vaccination. | Occurrence of adverse reactions within 42 days after the vaccination. | within 42 days after the vaccination |
| Occurrence of severe adverse reactions after the vaccination | Occurrence of severe adverse reactions within 13 months after the vaccination | within 13 months after the vaccination |
| Geometric mean titre of serum for antibody responses 42 days post-vaccination | Geometric mean titre of Serum for antibody responses at day 42 post-vaccination | 42 days after the vaccination |
| Geometric mean fold increase of serum for antibody responses 42 days post-vaccination | Geometric mean fold increase of Serum for antibody responses at day 42 post-vaccination | 42 days after the vaccination |
| Four-fold increase rate of serum for antibody responses 42 days post-vaccination | Four-fold increase rate of Serum for antibody responses at 42 day post-vaccination | 42 days after the vaccination |
| Geometric mean titre of serum for antibody responses 6 months post-vaccination | Geometric mean titre of Serum for antibody responses at 6 months post-vaccination | 6 months after the vaccination |
| Geometric mean fold increase of serum for antibody responses 6 months post-vaccination | Geometric mean fold increase of Serum for antibody responses at 6 months post-vaccination | 6 months after the vaccination |
| Four-fold increase rate of serum for antibody responses 6 months post-vaccination | Four-fold increase rate of Serum for antibody responses at 6 months post-vaccination | 6 months after the vaccination |
| Geometric mean titre of serum for antibody responses 13 months post-vaccination. | Geometric mean titre of Serum for antibody responses at 13 months post-vaccination | 13 months after the vaccination |
| Geometric mean fold increase of serum for antibody responses 13 months post-vaccination. | Geometric mean fold increase of Serum for antibody responses at 13 months post-vaccination | 13 months after the vaccination |
| Four-fold increase rate of serum for antibody responses 13 months post-vaccination. | Four-fold increase rate of Serum for antibody responses at 13 months post-vaccination | 13 months after the vaccination |
| Hanzhou |
| Zhejiang |
| 310051 |
| China |
| D007239 | Infections |