SBIR TOPIC 081: ADJUVANT DEVELOPMENT FOR VACCINES AGAINST INFECTIOUS OR IMMUNE-MEDIATED DISEASES

Goal is to develop the novel, parasite-derived, antigen-sparing protein adjuvant ASP-1 for flu vaccines to provide protection against a wide variety of seasonal and potentially also pandemic flu viruses. The vaccines are designed based on two pre-pandemic flu vaccines that, in humans with natural immunity against flu viruses due to previous infection and/or vaccination, boost antibody responses specific to conserved flu epitopes. Specifically, Aim 1 will optimize production of ASP-1 in a form suited for clinical application and establish its stability profile. Aim 2 will verify the adjuvanticity of ASP-1 in mice and select a lead vaccine composition by optimizing the ratio among vaccine antigens and ASP-1, based on the broadness and magnitude of the antibody responses. Aim 3 will test the protective effects by the lead based on viral titers and survival and establish its safety profile based on local and systemic effects. Our expectation is that the addition of ASP-1 to the vaccine will further enhance cross-protective immune responses and survival conferred by the vaccine. The studies under this contract will generate a product that will be (i) the first protein adjuvant to be approved in the U.S. and (ii) will address a significant unmet need: universal flu vaccines.