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Production of Adjuvants


Fast-Track proposals will be accepted. Direct-to-phase II proposals will be accepted. Number of anticipated awards: 3-5 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. Background Many experimental and licensed vaccines depend on adjuvants to exert their protective effect. While several immunostimulatory compounds and formulations are available commercially for use in preclinical studies, these compounds generally cannot be advanced into clinical trials. Furthermore, head-to-head comparisons of novel experimental adjuvants with those used in licensed vaccines or at late stages of clinical development is hampered by limited access to such reagents. NIAID supports the discovery and development of novel adjuvants through different mechanisms; and this topic is intended to address the limited availability of adjuvants that mimic the functionality of those with a favorable clinical track record. This topic also supports the development of formulations with immunostimulatory components that are functionally, but not necessarily chemically, similar to those used in licensed vaccines or at late stages of development Project Goal Development, validation and production of adjuvants that are based on, or similar to, compounds or formulations successfully used (i.e., efficacious) in clinical trials or part of licensed vaccines, for use by the broader research community, either as commercial products or through licensing agreements. Phase I Activities must include at least the following 2 activities: • Development of one or more adjuvant/adjuvant formulations that are based on or similar to an adjuvant with a proven clinical track record of high adjuvanticity • Preclinical testing to assure immune potency and safety Phase II Activities include, but are not limited to: • Establishment of an immunological profile of the lead product • Pharmacological and toxicological studies in appropriate animal models • Validation of product • Scale-up production • Development of a marketing plan This SBIR will not support: • Development of aluminum-based adjuvants as marketable products, unless the aluminum-component is used as a co-adjuvant or carrier • Discovery of novel immunostimulatory compounds • Commercial development of adjuvants that do not have the ability or potential to activate human immune cells • The conduct of clinical trials (see for the NIH definition of a clinical trial) • Intellectual Property: The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the awardee to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project. .
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