Advanced development of a novel nanoparticle conjugate vaccine for Salmonella Paratyphi A

Salmonella Paratyphi ASParatyphi Ais a major cause of life threatening enteric feverThere is no vaccine available against this pathogenIn the SBIR phase I studieswe have successfully demonstrated the technical feasibility of a novel nanoparticle conjugate vaccine candidate for SParatyphi AIt is based on O polysaccharideOPSantigen conjugated to a novel and highly advantageous nanoparticle protein carrier found exclusively in bacteria and archaeaBasic processes for generation of purified polysaccharide antigen and carrier protein and their chemical conjugation were successfully establishedThe resulting conjugates were shown to be highly immunogenic in animal studiesWe propose to continue development of this novel conjugate vaccine in this phase II proposal with activities including advanced immunogenicity evaluationpilot cGMP process and assay developmentstability studyand animal toxicology study which will form the basis for the clinical stage developmentSuccessful development and licensure of this vaccine in the US will meet a significant unmet need for protection of high risk US populations in light of the increasing prevalence of SParatyphi A in other parts of world and ever increasing international travelsIt could also lead to a new and more effective nanoparticle based approach for conjugate vaccines