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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
25,000
subcutaneous injection
subcutaneous injection
Jiangsu Province Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Zhejiang Provincial Center for Disease Control and Prevention
Hanzhou, Zhejiang, China
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
Time frame: 30 days - 13 months after the vaccination
The incidence of herpes zoster after vaccination
The incidence of herpes zoster diagnosed in participants after vaccination.
Time frame: 0 day-13 months after the vaccination
The incidence of laboratory-confirmed herpes zoster 30 days to 13 months after vaccination
The incidence of laboratory-confirmed herpes zoster diagnosed in participants 30 days to 13 months after vaccination.
Time frame: 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.
Time frame: within 14 days after the vaccination
Occurrence of adverse reactions after the vaccination.
Occurrence of adverse reactions within 42 days after the vaccination.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 13 months after the vaccination
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