Henan Provincial Center for Disease Control and Prevention
Zhaoge, Henan, 450016, China
NCT Number: NCT04072497
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.
Looking for future studies?
Notify Me40 year and older
All sexes
Interventional
Phase 1 / Phase 2
Zhaoge, Henan, 450016, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 0 days-6 months after the vaccination
Time frame: 30 days after the vaccination
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
For each group serum titre with FAMA test
Time frame: 30 days after the vaccination
For each group serum titre with FAMA test
Time frame: 0 days-6 months after the vaccination
Time frame: 0 days-6 months after the vaccination
Time frame: 90 days-360 days after vaccination
The antibody titer measured by FAMA postvaccination in day 90,180,360
Shanghai Institute Of Biological Products
Industry
A Safety and Immunogenicity Study of a Zoster Vaccine in Healthy Adults >= 40 Years
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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