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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 developed by Inovio Pharmaceuticals, Inc. (ticker INO). It is a DNA plasmid vaccine candidate designed against H5N1 avian influenza virus and is delivered with electroporation. It has been studied in healthy adult volunteers in the United States.
VGX-3400X was studied for protection against H5N1 avian influenza virus in healthy adults. The single clinical trial enrolled healthy volunteers rather than patients with an active infection, so the program was evaluated as a preventive candidate against avian influenza.
VGX-3400X is developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. Inovio sponsored the clinical study of the candidate. The company is the sole developer named for this asset.
VGX-3400X is in Phase 1 development. Its only recorded clinical trial, NCT01142362, has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA.
VGX-3400X has been evaluated in one clinical trial, NCT01142362, titled "Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults." The Phase 1 study enrolled 32 healthy adult volunteers in the United States and is now completed.
The Phase 1 trial NCT01142362 was a controlled study of VGX-3400X in healthy adults aged 18 years and older, with both sexes eligible. It enrolled 32 participants in the United States and was not randomized or double blinded. The study has been completed.