Phase 12 Study to Assess Safety and Immune Response of Different Doses of a Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years and Older

What this Trial Is About

Researchers are studying a new lyophilized herpes zoster virus mRNA vaccine in healthy adults aged 40 years and older. The study aims to evaluate the safety and immune response of this vaccine, with Part A focusing on initial safety and immune effects, and Part B aiming to find the best dose and schedule in adults aged 50 and older. This trial is randomized, double-blind, and controlled to ensure accurate assessment of the vaccines effects. Participants receive two doses of the study vaccine with varying dosages and schedules or comparator vaccines including live attenuated vaccine, recombinant zoster vaccine, or placebo. In Part A, all participants get two doses of the mRNA vaccine given 30 or 60 days apart. In Part B, participants are randomly assigned to different doses or comparator vaccines with safety and immune responses monitored throughout. Immune response durability is also checked at several points after vaccination. During the study, participants undergo safety monitoring and immune testing including blood tests for antibody levels and cellular immunity. Researchers record adverse reactions within 30 days after each dose and track serious side effects for up to 12 months. Immune responses are measured at multiple timepoints after vaccination to assess antibody levels and T cell activity. Participants are expected to comply with visits, sample collections, and vaccination schedules throughout the study, which continues with long-term observation of immune persistence.

Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine