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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
522
One shot of the zoster vaccine (with live virus \>=4.3 LgPFU per dose)
One shot of the varicella vaccine (with live virus \>=3.3 LgPFU per dose)
one shot of placebo with no live virus
Henan Provincial Center for Disease Control and Prevention
Zhaoge, Henan, China
Reactogenicity in the group of live attenuated zoster vaccine
* The incidence rate of subjects with solicited AE(s) with 95% confidence interval * The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Time frame: 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.
Time frame: 30 days after the vaccination
VZV specific serum geometric mean titre
For each group serum titre with FAMA test
Time frame: 30 days after the vaccination
VZV specific serum geometric mean fold increase
For each group serum titre with FAMA test
Time frame: 30 days after the vaccination
Reactogenicity in the group of live attenuated varicella vaccine
* The incidence rate of subjects with solicited AE(s) with 95% confidence interval * The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Time frame: 0 days-6 months after the vaccination
Reactogenicity in the group of placebo
* The incidence rate of subjects with solicited AE(s) with 95% confidence interval * The incidence rate of subjects with solicited SAE(s) with 95% confidence interval
Time frame: 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
Time frame: 90 days-360 days after vaccination
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