Approval Probability
TA Base Rate
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ML Risk
VGX-3400X · 1 trial · 1 indication
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...
VGX-3400X is an investigational monoclonal antibody being developed by Inovio Pharmaceuticals, Inc. (INO). It was studied in a Phase 1 clinical trial for use in healthy adults as a potential preventive measure against H5N1 avian influenza. The drug is still in clinical development and is not approved.
VGX-3400X was evaluated in a Phase 1 trial for use in healthy adults as a potential preventive measure against H5N1 avian influenza virus. The study aimed to assess the safety and immune response of the drug when administered with electroporation. It remains investigational and is not yet approved for any use.
VGX-3400X is developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded under the ticker symbol INO. Inovio conducted a Phase 1 clinical trial of VGX-3400X in the United States. The drug is still in clinical development.
VGX-3400X is in Phase 1 clinical development. A Phase 1 trial, NCT01142362, has been completed. The drug is investigational and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated.
VGX-3400X was studied in one completed Phase 1 clinical trial, NCT01142362, titled "Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults." The trial enrolled 32 healthy adults in the United States and was controlled but not randomized or double-blinded.