Testing of a Novel Skin Electroporation Procedure for Multivalent Alphavirus DNA Vaccine Delivery

Ichor has developed an electroporation (EP) based device for DNA vaccine delivery in skin. In its current format, this simple, integrated device, called the intradermal TriGrid Delivery System (TDS-ID), has exhibited promise for delivery of monovalent DNA vaccines. Under SBIR Phase I, the TDS-ID will be adapted for multivalent DNA vaccine delivery. Feasibility of TDS-ID for this application will be evaluated in non-clinical studies using a trivalent DNA vaccine against the CDC category B biothreats Venezuelan (VEEV), eastern (EEEV), and western (WEEV) equine encephalitis viruses. There are currently no licensed human vaccines for VEEV, EEEV, or WEEV. The multivalent DNA vaccine candidate, developed in collaboration with USAMRIID, offers the potential for inducing target levels of immune response via a non-infectious vaccine candidate that is inexpensive to produce and simple to deploy. A range of vaccine formulation and injection conditions will be studied in rabbits to identify an administration procedure inducing multi-specific immune responses with an acceptable safety profile. If Phase I milestones are achieved, Phase II will comprise non-clinical protective efficacy testing of the TDS-ID device configured for multivalent DNA immunization. The overall program objective is development of a clinical TDS-ID device for multi-antigen DNA vaccination in biodefense applications.