Adjuvant Development for Vaccines for Infectious and Immune-Mediated Diseases

Fast-Track proposals will be accepted. Direct-to-phase II proposals will be accepted. Number of anticipated awards: 1-3 Budget (total costs): Phase I: $300,000/year for up to 2 years Phase II: $1,000,000/year with appropriate justification by the applicant for up to 3 years Mission: IID and BIOD COR: Kentner Singleton Background The goal of this program is to support the pre-clinical development of vaccine adjuvants for use in vaccines to prevent or treat human disease caused by infectious pathogens or immune-mediated diseases (e.g., allergic diseases, autoimmune diseases). Vaccine adjuvants are agents that stimulate and direct the immune system, which are used to enhance or modulate immune responses to a target antigen. The quality, magnitude, tissue distribution, isotype and subclass, and duration of antibody responses elicited by a vaccine can be influenced by the choice of adjuvant. Adjuvants also can drive antigen specific CD8 T cell responses, which are important for eliciting protection against some target pathogens. Adjuvants are used to specifically improve vaccine efficacy in at-risk populations such as neonates, young children, pregnant women, the immunocompromised, and the elderly as these populations have unique immune system characteristics and needs. Adjuvants can broaden vaccine accessibility worldwide by reducing the effective antigen dose or booster requirements, thereby extending the number of doses available or simplifying immunization schedules. Within the context of immunemediated diseases (e.g., allergy, autoimmunity), adjuvants could drive immune deviation (e.g., Th2 to Th1 immune response) or induce immune unresponsiveness/tolerance in an antigen-specific manner (e.g., Treg induction). In the field of allergic diseases, adjuvants could help reduce the dose, frequency, and duration of allergen administration in the context of allergen immunotherapy and reduce adverse allergic reactions thus leading to higher acceptance and effectiveness. New, improved, and widely accessible adjuvants are needed to support vaccine development. Because different pathogens or immune-mediated diseases require different immune responses for protection or treatment, each vaccine will require an appropriate adjuvant. Some adjuvants have increased or decreased vaccine efficacy in different populations; for example, a vaccine for use in the elderly may require a different adjuvant than one for a pediatric population. Different routes of administration (intranasal vs. intramuscular) or antigens can have different formulation needs, which some adjuvants are able to accommodate, while others cannot. Finally, intellectual property (IP) can re.strict use of an established vaccine adjuvant, where having additional options, including functional mimics of late-stage adjuvants or adjuvants in licensed vaccines, would offer more flexibility to vaccine developers, for the net benefit of the public