Description:
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
