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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05743335 | A Phase 1 Study to Assess the Safety and Immunogenicity of JCXH-221, an MRNA-based Broadly Protective COVID-19 Vaccine | PHASE1 | COMPLETED | 73 | — | — | Mar 7, 2023 | Dec 1, 2023 | Sep 19, 2024 | 4 | United States |
Frequency of serious adverse events (SAEs) characterized by type, severity, duration, and drug relationship, from Day 1 (dosing day) until follow-up completion
Solicited local reactions at the injection site characterized by frequency, severity, and duration, recorded up to 7 days after dosing (Day 8)
Solicited systemic reactions characterized by frequency, severity, duration, and drug relationship, recorded up to 7 days after dosing (Day 8)
Adverse events (AEs), including unsolicited AEs, characterized by frequency, severity, duration, and drug relationship, for up to 28 days after dosing (Day 29)
The proportion of subjects with at least 1 unsolicited treatment-emergent AE occurring up to 28 days after dosing (Day 29)
Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and drug relationship, from Day 1 until follow-up completion
| Arm | Type | Description |
|---|---|---|
| Investigational product | EXPERIMENTAL | Patients randomized to this arm will be given the investigational product (JCXH-221). |
| Placebo | PLACEBO_COMPARATOR | Patients randomized to this arm will be given a placebo vaccine. |
| Name | Type | Description |
|---|---|---|
| JCXH-221 | BIOLOGICAL | Participants will be randomized to either placebo or JCXH-221 for Phase 1. For Phase 2, participants will either be randomized to JCXH-221 or a FDA approved Active comparator. |
| Placebo | OTHER | Participants will be randomized in Phase 1 to either JCXH-221 or placebo |
Main Inclusion Criteria * Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. * Age: 18 years of age or older, at screening. * Status: Healthy subjects. * Subjects must have completed the full doses for primary vaccination with an ...