The identification of an effective and tolerable delivery method is a necessity for the success of DNA vaccines in the clinic. The objective of this proposal is to continue the development of the effective, tolerable, multi-agent DNA vaccine dermal electroporation device, validate this device and the resulting immune responses in appropriate animal models and additionally research the feasibility of adding a combined injection method. In the Phase I application, we optimized the device design of our current dermal prototype, named the minimally invasive device (MID-II), and demonstrated the feasibility of building a multi-headed device which would be applicable for delivering multiple DNA vaccines simultaneously. The new multi-head device is an efficient, tolerable and non-invasive method to deliver plasmid DNA simultaneously but spatially separated, negating issues of vaccine interference. Phase II research will validate the devices ability to deliver efficiently DNA vaccines of military interest (namely Haanta, Pummla, Arenavirus and Pandemic Influenza). We also propose to investigate the development and manufacture of low-cost sterile disposables for the device and the possibility of integrating dermal injection capabilities into a combined inject/EP device platform. This proposal seeks to further validate and advance our multi-agent delivery device and produce a clinically ready application.
Keywords: Electroporation, Dermal, Noninvasive, Tolerable, Multi-agent, DNA vaccine.
