The objective of this study was to evaluate the safety, immunogenicity and immune persistence of recombinant herpes zoster vaccine (CHO cells) with different adjuvant doses in healthy people aged 40 years and older.
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The incidence of solicited local and systemic adverse events (AEs) within 0-14 days after each vaccine dose.
Timeframe: Within 14 days after each vaccine dose.
The incidence of unsolicited adverse events (AEs) within 0-30 days after each vaccine dose.
Timeframe: Within 30 days after each vaccine dose.
The incidence of laboratory abnormalities (including blood biochemistry, blood routine, urine routine and electrocardiogram) on Day 3 after each vaccine dose.
Timeframe: On Day 3 after each vaccine dose.(Applicable to Phase I only)
The incidence of serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) from the vaccination of the first dose to 12 months after full immunization.
Timeframe: From the vaccination of the first dose to 12 months after full immunization.
The cell-mediated immune response rate of CD4+ T cells expressing at least two activation markers (IFN-γ, IL-2, TNF-α, CD40L) one month after full immunization.
Timeframe: One month after full immunization.(Applicable to Phase Ⅱ only)
The GMC/GMT, seroconversion rate, and GMI of anti-gE antibodies and anti-VZV antibodies one month after full immunization.
Timeframe: One month after full immunization.(Applicable to Phase Ⅱ only)