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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05871541 | A First-in-Human Study to Evaluate JCXH-105, an SrRNA-based Herpes Zoster Vaccine | PHASE1 | COMPLETED | 75 | — | — | May 26, 2023 | Mar 25, 2024 | Sep 19, 2024 | 3 | United States |
Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion
Solicited local injection site reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)
Solicited systemic adverse reactions characterized by frequency, severity, and duration recorded within 7 days after each vaccine administration (JCXH-105 or Shingrix)
Adverse events (AEs) including unsolicited AEs, characterized by type, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration to within 30 days following each vaccine administration
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration (JCXH-105 or Shingrix) through follow-up completion
Potential immune-mediated disease (pIMDs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration (JCXH-105 or Shingrix) through follow-up completion
| Arm | Type | Description |
|---|---|---|
| Investigational Product | EXPERIMENTAL | Participants randomized to this arm will be given the investigational product (JCXH-105). |
| Active Control | ACTIVE_COMPARATOR | Participants randomized to this arm will be given the FDA approved Shingrix. |
| Name | Type | Description |
|---|---|---|
| JCXH-105 | BIOLOGICAL | As IM injection |
| Active Control (Shingrix) | BIOLOGICAL | As IM injection |
Inclusion Criteria: * Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. * Age: 50 to 69 years of age, inclusive, at screening. * Status: Healthy subjects. Note: Healthy status as defined by the absence of evidence of any clinical...