This contract will support a preclinical and clinical testing program designed to advance the development of a candidate combination DNA vaccine for hemorrhagic fever with renal syndrome (HFRS) caused by Hantaviruses using a cross-cutting delivery technology to accelerate protective immune responses. Specifically, the contractor will use the recently developed intradermal electroporation (ID-EP) delivery system to deliver the vaccine with the goal of improving the seroconversion rate. The scope of product development activities that may be addressed through this award span manufacturing and formulation process development through clinical studies, including: manufacturing, characterization and release of pilot lot cGMP material; vaccine stability testing ; conduct of non-clinical studies, e.g., Investigational New Drug (IND)-enabling toxicology studies; development, qualification and, where necessary, validation of all assays and reagents needed to support product development; and the delivery to the NIAID of 2000 doses of cGMP final container candidate.
