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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01184976 | Study Of VGX-3400, H5N1 Avian Flu Virus Plasmid DNA With Electroporation Device In Healthy Adult Males | PHASE1 | COMPLETED | 30 | — | — | Aug 1, 2010 | Apr 1, 2012 | Mar 17, 2015 | 2 | South Korea |
Frequency, severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events
| Arm | Type | Description |
|---|---|---|
| 0.6mg DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400 containing 0.6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| 2mg DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400 containing 2mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| 6mg DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| Name | Type | Description |
|---|---|---|
| VGX-3400 | BIOLOGICAL | Plasmid DNA delivered via IM injection with electroporation |
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI) * Male subjects 20-39 years of age * Healthy subjects as judged by the Investigator based on...