This clinical trial included two parts, Part A and Part B. The goal of Part A is to evaluate the safety and preliminary immunogenicity of the lyophilized herpes zoster virus mRNA vaccine (HZ mRNA vaccine) in healthy populations aged 40 years and older. The goal of Part B is to select the optimal dosage and schedule in healthy populations aged 50 years and older to support next further study.
This is a randomized, double-blind, controlled study. Part A employed sequential enrollment by age and dosage. All participants received two doses of the study vaccine. Safety observation conducted throughout the study. Humoral and celluar immunity were evaluated. In Part B, participants randomly received either different dosage study vaccine or active controlled vaccine, with different immunization schedule. Safety observation conducted throughout the study. Humoral and celluar immunity were evaluated. Immune persistence was also evaluated at multiple timepoints after vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
519
Lyophilized herpes zoster virus mRNA vaccine
Lyophilized herpes zoster virus mRNA vaccine
herpes zoster attenuated live vaccine, lyophilized
Xinjiang Uygur Autonomous Region Center for Disease Control and Prevention
Xinjiang, China
RECRUITINGThe incidence of adverse reactions within 30 days
The incidence of adverse reactions within 0\~30 days after each dose vaccination.
Time frame: 0~30 days after each dose vaccination
Seroconversion rate of gE antibody
The seroconversion rate of gE antibody on Day 30 after two doses vaccination.
Time frame: Day 30 after two doses
Geometric mean concentration (GMC) of gE antibody
The GMC of gE antibody on Day 30 after two doses vaccination.
Time frame: Day 30 after two doses
Adverse reactions within 0~14 days
The incidence of adverse reactions within 0\~14 days after each dose vaccination.
Time frame: 0~14 days after each dose vaccination
Incidence of serious adverse events (SAEs)
The incidence of SAEs from the first dose to 12 months after the second dose.
Time frame: From the first dose to 12 months after the second dose
Incidence of adverse events of special interest(AESI)
The incidence of AESI from the first dose to 12 months after the second dose.
Time frame: From the first dose to 12 months after the second dose
GMC of gE antibody
The GMC of gE antibody on Day 30 or Day 60 after the first dose, and on Day 14、Day 180 and Day 360 after the second dose
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14、Day 180 and Day 360 after the second dose
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Geometric mean fold rise (GMFR) of gE antibody
The GMFR of gE antibody on Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Seroconversion rate of varicella-zoster virus (VZV) antibody
The seroconversion rate of VZV antibody on Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose.
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
GMT of VZV antibody
The GMT of VZV antibody on Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
GMFR of VZV antibody
The GMFR of VZV antibody on Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose
Frequency of CD4/CD8+ T cells secreting gE-specific cytokines
The frequency of CD4/CD8+ T cells secreting gE-specific cytokines (IFN-γ, IL-2, TNF-α, CD40L) on Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose.
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14、Day 30、Day 180 and Day 360 after the second dose
Cellular immune response rate
The cellular immune response rate on Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose.
Time frame: On Day 30 or Day 60 after the first dose, and on Day 14 and Day 30 after the second dose