Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07400003 | Study to Evaluate the Safety and Immunogenicity of a Lyophilized Herpes Zoster Virus mRNA Vaccine | PHASE1 | RECRUITING | 519 | — | — | Jan 6, 2026 | Apr 30, 2027 | Feb 10, 2026 | 1 | China |
The incidence of adverse reactions within 0\~30 days after each dose vaccination.
The seroconversion rate of gE antibody on Day 30 after two doses vaccination.
The GMC of gE antibody on Day 30 after two doses vaccination.
| Arm | Type | Description |
|---|---|---|
| Low-dose group | EXPERIMENTAL | Participants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (low dosage), with 30 days or 60 days apart |
| High-dose group | EXPERIMENTAL | Participants will receive two doses of lyophilized herpes zoster virus mRNA vaccine (high dosage), with 30 days or 60 days apart |
| Comparator A | ACTIVE_COMPARATOR | Participants will receive a single dose of saline on day 0 and a single dose of herpes zoster vaccine, live on day 60 |
| Comparator B | ACTIVE_COMPARATOR | Participants will receive two doses of recombinant zoster vaccine (CHO cell), with 60 days apart |
| Comparator C | PLACEBO_COMPARATOR | Participants will receive two doses of saline, with 60 days apart |
| Name | Type | Description |
|---|---|---|
| Low-dose experimental vaccine | BIOLOGICAL | Lyophilized herpes zoster virus mRNA vaccine |
| High-dose experimental vaccine | BIOLOGICAL | Lyophilized herpes zoster virus mRNA vaccine |
| Active-controlled vaccine A | BIOLOGICAL | herpes zoster attenuated live vaccine, lyophilized |
| Active-controlled vaccine B | BIOLOGICAL | Shingrix® |
| Placebo group | OTHER | Saline |
Inclusion Criteria: * 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 effect...