drugset / Trial / NCT01142362

Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults

NCT01142362 ↗

Phase 1 Completed 32 enrolled Inovio Pharmaceuticals
Non-randomizedParallel-groupOpen-labelPrevention

Summary

DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans. The investigators have developed a DNA vaccine, VGX-3400X, which includes plasmids targeting the proteins of the H5N1 avian influenza virus. The vaccine will be delivered via electroporation (EP) which uses the CELLECTRA constant current device to deliver a small electric charge following injection, since animal studies have shown that this delivery method increases the immune response to vaccine. The vaccine will be given to 30 healthy adult subjects. It is hypothesized that VGX-3400X + EP will be well tolerated and immunogenic.

Timeline

Start
2010-06
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject VGX-3400X Vaccine 0.6 mg Intramuscular
Subject VGX-3400X Vaccine 2 mg Intramuscular
Subject VGX-3400X Vaccine 6 mg Intramuscular

Indications

No indication recorded.