The goal of our proposed research is to develop a Brucella vaccine that is safe for human use. Our approachhas explored the use of live attenuated vaccines, since subunit vaccines have shown little real promise. Ourapproach combines the optimal features of a deliverable vaccine that is safe, free of side effects andefficacious in humans with enhanced immune stimulation through microencapsulation. The competitiveadvantages and innovations of our approach are: (1) use of a highly attenuated, safe, gene knockout, liveB. melitensis mutants; (2) manufacturing with unique disposable closed system technologies, and (3)oral/intranasal delivery in a novel microencapsulation-mediated controlled release formula to optimallyprovide the long term mucosal immunostimulation required for protective immunity. Based upon ourpreliminary data, we postulate that our vaccine delivery system will ultimately be storage stable,administered orally or intranasally, and generally applicable to a number of select agents. We present a welldesigned5-year timeline with milestones for developing GMP-produced vaccine for vaccination-aerosolchallenge studies in non-human primates as a pathway to a clinical Investigational New Drug studies on thepath to FDA Biological License Application. The development of the proposed product takes full advantageof a strong team and ongoing research with bacterial genetics and testing in multiple animal models coupledwith novel manufacturing and microencapsulation technologies that balance product safety, stability, costs,and potency.
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