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Novel Vaccine Technologies and Strategies to Promote Sustained Vaccine Efficacy

Description:

Fast-Track proposals will be accepted. Number of anticipated awards: 2-3

Budget (total costs): Phase I: $450,000 for up to 2 years Phase II: $3,000,000 for up to 3 years
Background
There is an unmet need to improve vaccine performance to combat malaria and pertussis, which are considered significant public health threats. Recent advances in the field of malaria vaccine development have led to the achievement of significant milestones. Several malaria vaccines are now in late stage development or are being considered for widespread deployment. However, these vaccine candidates have only been shown to provide short-term protection, suggesting a need for further improvement. Similarly, widely accepted acellular vaccines for pertussis are showing waning protection, resulting in outbreaks of pertussis, a disease that was previously thought to have been controlled. Knowledge about immunological memory and correlates of vaccine protection is constantly evolving; newly available vaccine delivery tools, strategies, and formulations are currently being optimized with prototype antigens to develop vaccines with enhanced protective immunity. This contract topic aims to leverage the new knowledge and tools, and calls for the development of novel vaccine technologies and strategies that promote sustained vaccine efficacy against malaria or pertussis.
Project Goals
 To identify or develop novel vaccine technologies, such as delivery platforms or formulations, that induce long-term protection against malaria or pertussis;  To develop new vaccines or vaccine strategies using technologies that induce long-term immunity and sustainable efficacy against malaria or pertussis.
Phase I activities can include but are not limited to:
 Identification and evaluation of novel formulations (e.g., adjuvants, adjuvant systems), delivery platforms (e.g., viral vectors), or vaccine strategies (e.g., novel prime-boost regimens) to induce long-term immunity or surrogate markers for long-term protection;
 Development of in vitro surrogate assays to evaluate induction of long-term immunity or protection using
phenotypic markers;
 In vivo proof-of-concept studies to demonstrate sustainable protection in appropriate animal models.
Phase II activities can include but are not limited to:
 Additional testing and process development of the lead technologies and/or vaccine candidate(s) in the product development pathway leading to IND-enabling studies, including but not limited to testing to improve safety, efficacy, and QA/QC;
 Further definitive preclinical testing in non-human primate models;
 Pilot lot cGMP manufacturing, as appropriate, for further refinement of the vaccine candidate(s);
 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 http://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.
 Technology development using prototype antigens other than known or newly identified protective antigens for malaria and pertussis.

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