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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01142362 | Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults | PHASE1 | COMPLETED | 32 | — | — | Jun 1, 2010 | Nov 1, 2011 | Sep 13, 2017 | 2 | United States |
Frequency and severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| 0.6mg of DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400X containing 0.6 mg 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-3400X containing 2mg of 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-3400X containing 6 mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| Name | Type | Description |
|---|---|---|
| VGX-3400X | BIOLOGICAL | DNA plasmids delivered via IM injection + electroporation using CELLECTRA device |
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); * Adults of either gender 18-50 years of age; * Healthy subjects as judged by the Investiga...