A Randomized, Double-Blind, Controlled Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of Different Doses of a Lyophilized Herpes Zoster Virus mRNA Vaccine in Adults Aged 40 Years and Older
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.
• Phase I: Age ≥ 40 years; Phase II: Age ≥ 50 years;
• Participants are able to understand and voluntarily sign the informed consent form;
• Able to provide legal identification;
• Participants of childbearing potential and their sexual partners agree to voluntarily adopt effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose of the investigational vaccine, with no plans for sperm or egg donation;
• Agree to comply with the visit schedule, sample collection, vaccination, and other trial procedures throughout the study period, and remain accessible at all times during the trial.