This Project's primary goal is to develop the use of gamma inulin-based adjuvants as safe and effective adjuvants for use in vaccines against Category A, B and C bioterrorism pathogens. As adjuvants cannot receive regulatory approval in their own right but only as part of a vaccine composition, a further objective is to develop at least one vaccine against a Category A, B or C pathogen by combining gamma inulin-based adjuvant with pathogen derived proteins or peptides. Specific components of the project include the physico-chemical characterization, and optimization of inulin-based adjuvants for use in bioterrorism subunit vaccines, determination of the mechanisms of action of inulin-based adjuvants, thereby creating the ability to develop further novel nontoxic adjuvants that utilize similar immuno-stimulatory pathways, validation of the biological activity of inulin-based adjuvants in combination with model pathogen-derived antigens (e.g. Q Fever, Shigella, flaviviruses, small pox, SARS), proof of concept studies demonstrating vaccine protection in validated animal infection models and pre-clinical safety and toxicology studies to enable inulin-based adjuvants to advance into phase 1 human trials. Although pure recombinant antigens although undoubtedly safer than whole organism vaccines, a major problem is their general lack of immunogenicity. This has created a major demand for more potent yet safe adjuvants not associated with unacceptable toxicity. Hence the urgent need for a well tolerated and effective adjuvant capable of boosting both cellular and humoral immunity. Inulin-based adjuvants offer just such advantages and should work well in combination with bioterrorism vaccines.
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