A Phase Ⅲ Clinical Study to Evaluate Protective Efficacy and Safety of a Recombinant Herpes Zoster Vaccine

PHASE3RecruitingINTERVENTIONAL
Enrollment

4

Participants

Timeline

Start Date

September 28, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2026

Conditions
Vaccine-Preventable DiseasesHerpes Zoster
Interventions
BIOLOGICAL

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.

BIOLOGICAL

Recombinant Herpes Zoster Vaccine Placebo

Alumina adjuvant

Trial Locations (1)

210009

RECRUITING

Jiangsu Province Center for Disease Control and Prevention (China), Zhenjiang

All Listed Sponsors
lead

Beijing Luzhu Biotechnology Co., Ltd.

OTHER