The purposes of the study are to evaluate the Safety, Tolerability, and Immunogenicity of different dose levels of recombinant herpes zoster vaccine with 2 doses 60 days apart in healthy subjects aged 40 years and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
540
Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;
Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Immunization procedure: 2 doses, 60 days apart;
The placebo in this study is 0.9% sodium chloride (normal saline) injection; Immunization procedure: 2 doses, 60 days apart;
Dazhu CDC
Dazhou, Sichuan, China
phase 1: Incidence and intensity of solicited adverse events (AEs)
Time frame: within 14 days after each vaccination
phase 1: Incidence and intensity of unsolicited AEs
Time frame: within 30 days after each vaccination
phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody
Time frame: at 30 days after full vaccination
phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody
Time frame: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
phase 1:Frequency and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by intracellular cytokine staining (ICS)
Time frame: at 30 days after the first vaccination, before the second vaccination, and at 30 days after full vaccination
phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Time frame: during the study (from the first vaccination to 12 months after full vaccination)
phase 1: Incidence and intensity of abnormal laboratory tests indicators
Time frame: 3 days after each vaccination
phase 2: GMI of antigen-specific antibody
Time frame: at 30 days after full vaccination
phase 2: GMC, GMI, and seroconversion rate of antigen-specific antibody
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Route of vaccination: intramuscular injection into the lateral deltoid of the upper arm; Dosage of vaccination: 50 μg; Immunization procedure: 2 doses, 60 days apart
Route of vaccination: subcutaneous injection into the lateral deltoid of the upper arm; Dosage of vaccination: 0.5 mL; Immunization procedure: saline will be administered at Day 0, and Ganwei® will be administered at Day 60;
Time frame: before the second vaccination, and at 6 months, 12 months and 24 months after full vaccination
phase 2: GMT/GMC, GMI, and seroconversion rate of VZV-specific antibody
Time frame: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination
phase 2: Frequencies and response rate of CD4+ T cells with antigen-specific TNF-α and/or IFN-γ and/or IL-2 and/or CD40L secretion/expression as determined by ICS
Time frame: before the second vaccination, and at 30 days, 6 months, 12 months and 24 months after full vaccination
phase 2: Incidence and intensity of solicited AEs
Time frame: within 14 days after each vaccination
phase 2: Incidence and intensity of unsolicited AEs
Time frame: within 30 days after each vaccination
phase 2: Incidence of SAEs and AESIs
Time frame: from the first vaccination to 12 months after full vaccination