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Vaccines against Pathogens with Small Market Potential

Background
There is an urgent need to develop vaccines against pathogens affecting a relatively small segment of the US population.  While the market or segment of the overall population affected may be statistically small, the morbidity and mortality in some cases can be quite substantial. NIAID is interested in receiving proposals to develop vaccines against small or limited market-type pathogens.  Specific examples of unmet vaccine needs that would fit this request would be Coccidioidomycosis/San Joaquin Valley Fever (VF), Lyme disease, as well as vaccines for selected high risk populations.
Project Goal
?       To promote identification, characterization, validation, and ultimately product development of potential vaccines against pathogens with limited market potential. 
?       To encourage collaboration between academic researchers and small business entities to discover, validate and produce vaccines for pathogens with small market potential.
Phase I activities include but are not limited to
?       Identification, characterization, and validation of vaccine candidates
?       Development of in vitro assays to qualify vaccine candidates for future product development
?       Selection of adjuvant, as appropriate, for further development and antigenicity testing
Phase II activities include but are not limited to
?       Additional testing of the lead vaccine candidate(s) in the vaccine product development pathway leading to IND-enabling studies, including but not limited to testing to improve safety, efficacy, and QA/QC
?       Pilot lot of cGMP manufacturing for further refinement of the vaccine candidate(s)
?       Formulation, stability, and toxicology studies, as appropriate, for later stages of the vaccine product development pathway
This SBIR will not support:
?       The design and conduct of clinical trials (see https://www.niaid.nih.gov/researchfunding/glossary/pages/c.aspx#clintrial) for the NIH definition of a clinical trial). For SBIR phase II clinical trial support, see the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement program announcement.
?       Platform development such as vehicle or delivery systems.
National Institute on Drug Abuse (NIDA)
NIDA?s mission is to lead the nation in bringing the power of science to bear on drug abuse and addiction, through support and conduct of research across a broad range of disciplines and by ensuring rapid and effective dissemination and use of research results to improve prevention, treatment, and policy.
 
This solicitation invites proposals in the following areas:

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