Development of a Cytomegalovirus DNA Vaccine

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DESCRIPTION (provided by applicant): The specific AIM of this Phase I SBIR proposal from Vical Incorporated is to move forward an immunotherapeutic vaccine for cytomegalovirus (CMV) from preclinical to clinical development. Vical has undertaken a program that focuses on the prevention of CMV viremia, disease, and associated complications in patients undergoing either hematopoietic or solid organ transplantation. The vaccine is a bivalent construct that encodes modified genes for the proteins gB and pp65, and is formulated in the poloxamer CRL 1005 in order to enhance B and T cell responses. This SBIR proposal will support that development through the final phases of pre-clinical safety studies, assay development, manufacturing, and planning for a Phase I clinical trial in humans. The specific milestone to be reached for moving to Phase II of the SBIR program will be to have the IND allowed in preparation to enroll the first patient by the end of 2003. The work plan takes the development process from the point of this project in March 03 forward to the IND allowance, estimated to occur on approximately 10/30/03. The specific goals to be achieved during that time, and financed in part by this Phase I SBIR application, include 1) the conduct of the pre-clinical safety and toxicology studies, 2) clinical protocol and site development, 3) the manufacture of GMP products, 4) the preclinical analytic testing plan and assay development, and 5) development of the clinical immunogenicity assays needed to support the clinical trials.