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A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine
Sponsor: Beijing Luzhu Biotechnology Co., Ltd.
Summary
This clinical trial is to study protective efficacy and safety of a recombinant herpes zoster vaccine (LZ901) and sponsored by Beijing Luzhu Biotechnology Co., Ltd. It is a phase Ⅲ, randomized, double-blind, placebo-controlled in healthy people aged 40 years and older. The study is to protect adults against shingles (herpes zoster / varicella zoster virus(VZV)). There will be about 26000 participators who will receive two-dose injection at the upper arm. LZ901 vaccine is made up of a tetramer of VZV glycoprotein E (VZV gE-Fc) and adsorbed with aluminum hydroxide adjuvant. This adjuvant can raise the immune response to a lot of antigens. It is the most widely used and safe adjuvant in various types of vaccines worldwide.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety, and Immunogenicity of Recombinant Herpes Zoster Vaccine (CHO Cells) in Subjects Aged 40 Years and Older
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4
Start Date
2023-09-28
Completion Date
2026-12-31
Last Updated
2023-10-18
Healthy Volunteers
Yes
Interventions
Recombinant Herpes Zoster Vaccine
The active ingredient of the recombinant herpes zoster vaccine is varicella-zoster virus glycoprotein E fusion protein expressed in CHO cells by gene recombination technology. The LZ901 cell line carrying this gene is cultured in chemically defined medium. The harvest cell culture is purified by multi-step liquid chromatography. After Low pH incubation and virus removal filter package Nanofiltration inactivation/virus removal process, the bulk containing high-purity recombinant herpes zoster virus glycoprotein E is obtained. Finally, an alumina adjuvant is added to the formulated final product.
Recombinant Herpes Zoster Vaccine Placebo
Alumina adjuvant
Locations (1)
Jiangsu Province Center for Disease Control and Prevention (China)
Zhenjiang, Jiangsu, China