A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NIAID 128

Topic

Adjuvant Development for Vaccines for Infectious and Immune-Mediated Diseases

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The Department of Health and Human Services, specifically the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC), are seeking proposals for Small Business Innovation Research (SBIR) contract proposals. The solicitation, titled "Adjuvant Development for Vaccines for Infectious and Immune-Mediated Diseases," aims to support the pre-clinical development of vaccine adjuvants for use in vaccines to prevent or treat human diseases caused by infectious pathogens or immune-mediated diseases. Vaccine adjuvants are agents that stimulate and direct the immune system, enhancing or modulating immune responses to a target antigen. They can influence the quality, magnitude, tissue distribution, isotype and subclass, and duration of antibody responses elicited by a vaccine. Adjuvants also play a role in driving antigen-specific CD8 T cell responses, which are crucial for protection against certain pathogens. Adjuvants are particularly important in improving vaccine efficacy in at-risk populations such as neonates, young children, pregnant women, the immunocompromised, and the elderly, who have unique immune system characteristics and needs. The solicitation emphasizes the need for new, improved, and widely accessible adjuvants to support vaccine development. Different pathogens or immune-mediated diseases require different immune responses for protection or treatment, necessitating the use of appropriate adjuvants for each vaccine. Adjuvants can also accommodate different routes of administration or antigens with varying formulation needs. Additionally, having additional options, including functional mimics of late-stage adjuvants or adjuvants in licensed vaccines, would offer more flexibility to vaccine developers. The solicitation accepts Fast-Track proposals and Direct-to-phase II proposals. The anticipated number of awards is 1-3, and the budget specifics are as follows: - 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 The project duration and funding specifics are provided to guide potential applicants. The solicitation is closed, and more information can be found on the grants.gov website (solicitation_agency_url) and the SBIR topic link (sbir_topic_link).

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