Study of a DNA-based Venezuelan Equine Encephalitis Virus DNA Vaccine Administered by Electroporation in Healthy Volunteers

Summary

The Phase I study will assess the basic safety, tolerability, and immunogenicity of a DNA-based Venezuelan equine encephalitis virus (VEEV)vaccine candidate delivered by electroporation . The study will enroll 40 healthy adult volunteers ages 18-49 and will comprise evaluation of intradermal or intramuscular administration by electroporation. Administration of the vaccine candidate will be at two DNA dose levels (0.5 mg/ml and 2.0 mg/ml) for each route of administration. Electroporation will be administered using the TriGrid Delivery System devices for intramuscular and intradermal delivery. An additional group of subjects will serve as a placebo control, receiving injections of saline with electroporation. The overall goal of this study will be to determine if further human clinical studies of the vaccine candidate are warranted and, if so, to aid in the selection of dose and route of administration for future studies.

Timeline

Start

2013-12

Primary completion

2014-06

Completion

2015-05

Publications

• Hannaman D, Dupuy LC, Ellefsen B, Schmaljohn CS. A Phase 1 clinical trial of a DNA vaccine for Venezuelan equine encephalitis delivered by intramuscular or intradermal electroporation. Vaccine. 2016 Jun 30;34(31):3607-12. doi: 10.1016/j.vaccine.2016.04.077. Epub 2016 May 17.

Drugs

Indications