Vaccine Safety Studies against Brucellosis

Title: The use of the pregnant sheep model in vaccine safety studies against brucellosis

Funding Institution: National Institutes of Health NIH (R21)

Vaccine Safety Studies against BrucellosisDescription: The long-term goal of this proposal is to develop a safe and efficacious vaccine against brucellosis using the sheep model. Experiments in sheep are expected to provide the support for experimentation to test vaccine candidates in non-human primates with the ultimate goal of developing a Brucella vaccine that is safe and efficacious for human use. The efforts outlined have taken advantage of our recently developed platform (encapsulation) to prolong immune system stimulation without prolonging the survival of the vaccine strain. Using this innovative approach we have progressed through multiple levels of investigation to demonstrate efficacy and safety of the LAV providing strong justification to bring development to fruition. The competitive advantages and innovations of approach presented include: (1) evaluation of highly attenuated, safe, gene knockouts in well-established, stable genetic background; (2) safety evaluation under the most stringent conditions possible, (3) support for development of a nonhuman primate model; (4) potential to reduce biocontainment level and support for manufacturing (GMP) and future progress for clinical trials, production and distribution.