Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above

A Multicenter, Active-controlled, Randomized, Double Blinded, Parallel, Phase II Study to Assess the Immunogenicity and Safety of CVI-VZV-001 in Healthy Adults Aged 50 Years and Above

To evaluate the immunogenicity of the investigational product (IP) in healthy adults aged 50 years or older and to explore differences in immune responses between the experimental and control groups, and to determine the optimal dose of the IP.

Inclusion Criteria:

• Participants must meet all of the following criteria:

  • Healthy adults aged 50 years or older
  • Able to understand the study procedures and provide written informed consent
  • Females and males of reproductive potential must agree to use medically acceptable contraception until 3 months after the last vaccination
  • Females of childbearing potential must have a negative pregnancy test prior to vaccination

Exclusion Criteria:

• Participants meeting any of the following criteria will be excluded:

  • History of herpes zoster prior to screening
  • History of severe allergic reaction to vaccines or vaccine components
  • Known immunodeficiency or immune dysfunction
  • Prior vaccination with varicella or herpes zoster vaccine
  • Use of immunosuppressive therapy or systemic steroids that may affect immune response
  • Positive test for HCV, HBV, or HIV at screening
  • Pregnant or breastfeeding women
  • Any medical condition that, in the opinion of the investigator, would make participation unsafe or interfere with study evaluation