The overall aim of this Phase I proposal is to develop a two-phase polymeric vehicle for anthrax protective antigen and to demonstrate a protective immunity against anthrax bacterium and efficacy of the formulated antigen in a challenge test. The vaccination of combat forces would improve defensive capabilities essential for minimizing the impact of biological weapons. We will first screen polymers for antigen delivery using a proprietary nanodelivery technology. The designed system will include an internal polymer(s), preserving the antigen integrity and providing the mucoadhesive properties. The antigen release kinetics will be adjusted by several immobilization technologies and its integrity (bioavailability) tested. Furthermore, protective immunity in mice will be characterized via mucosal and systemic responses and the efficacy tested in a challenge test. The outcome of this project will be a formulated antigen construct allowing us to test the antigen efficacy with multiple antigens in Phase II and to develop this concept further. It will then be passed on to a suitable partner (as a license) or developed into a commercial product in house. PROPOSED COMMERCIAL APPLICATION: A unique nature of this technology would allow expansion of this concept for other pathogens of military significance and/or multiple antigen delivery with broader protective properties.
