044 Vaccine Adjuvant Screening and Discovery
Fast-Track proposals will not be accepted.
Direct-to-phase II proposals will be accepted
Number of anticipated awards: 1-3
Budget (total costs):
Phase I: $225,000 for up to 1 year
Phase II: $1,500,000 with appropriate justification by the applicant for up to 3 years
Vaccine adjuvants stimulate innate and/or adaptive immune responses. For the purpose of this SBIR, adjuvants are defined according to the U.S. Food and Drug Administration (FDA) as “agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen.” Currently, only three adjuvants have been licensed as components of vaccines in the United States - aluminum hydroxide/aluminum phosphate (alum), 4’-monophosphoryl lipid A (MPL), adsorbed to alum as an adjuvant for an HPV vaccine, and the oil-in-water emulsion MF59 as part of the Fluad influenza vaccine for people age 65 years and older. The gaps that need to be addressed by new adjuvants include improvements to existing, insufficiently efficacious vaccines (e.g., the acellular pertussis vaccine), and development of vaccines: for emerging threats (e.g., Ebola outbreaks); for special populations that poorly respond to existing vaccines (i.e., elderly, newborns/infants, immunosuppressed patients); or to treat/prevent immune-mediated diseases (e.g., allergen immunotherapy, autoimmunity, transplant rejection). Recent advances in innate immunity have provided a significant number of new putative targets for vaccine adjuvants. Simultaneously, progress is slowly being made in the identification of in vitro correlates of adjuvanticity which allows the design of in vitro screening assays to discover novel adjuvant candidates in a systematic manner.
The objective of this program is to support the screening for new adjuvant candidates, their characterization and early-stage optimization.
Phase I Activities include, but are not limited to:
• Optimize and scale-up screening assays to identify new potential adjuvant candidates
• Create targeted libraries of putative ligands of innate immune receptors
• Pilot screening assays to validate HTS approaches for identifying adjuvant candidates
• Develop in silico screening approaches to pre-select adjuvant candidates
Phase II Activities include, but are not limited to:
• High-throughput screening of compound libraries and confirmation of adjuvant activity of leads compounds
• Confirmatory in vitro screening of hits identified by HTS or in silico prediction algorithms
• Optimization of lead candidates identified through screening campaigns through medicinal chemistry and/or formulation
• Screening of adjuvant candidates for their usefulness in special populations, such as the use of cells from cord blood or infants and/or elderly/frail humans or animal models representing human special populations