Vacuna recombinante contra el herpes zóster en adultos sanos mayores de 40 años

Recombinant Herpes Zoster Vaccine (SCTV04C) Low-Dose

Recombinant Herpes Zoster Vaccine (SCTV04C) High-Dose

Placebo control: Saline

Shingrix®

Ganwei®

phase 1: Incidence and intensity of solicited adverse events (AEs)

phase 1: Incidence and intensity of unsolicited AEs

phase 2: Geometric mean concentration (GMC) and seroconversion rate of antigen-specific antibody

phase 1: Geometric mean titer (GMT)/ GMC, Geometric mean fold increase (GMI), and seroconversion rate of antigen-, and VZV-specific antibody

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)

phase 1: Incidence of Serious adverse events (SAEs) and Adverse events of special interest (AESIs)

phase 1: Incidence and intensity of abnormal laboratory tests indicators

phase 2: GMI of antigen-specific antibody

phase 2: GMC, GMI, and seroconversion rate of antigen-specific antibody

phase 2: GMT/GMC, GMI, and seroconversion rate of VZV-specific antibody

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

phase 2: Incidence and intensity of solicited AEs

phase 2: Incidence and intensity of unsolicited AEs

phase 2: Incidence of SAEs and AESIs