Development of a Cytomegalovirus DNA Vaccine

描述(由申请人提供)：Vical公司这项第一阶段SBIR提案的具体目标是将巨细胞病毒(CMV)的免疫治疗性疫苗从临床前发展到临床开发。VICAL已经开展了一项计划，重点是预防接受造血或实体器官移植的患者的CMV病毒血症、疾病和相关并发症。该疫苗是一种二价结构，编码蛋白质GB和pp65的修饰基因，并在泊洛沙姆CRL 1005中配制，以增强B和T细胞反应。这项SBIR建议将通过临床前安全性研究的最后阶段、分析开发、制造和计划在人体上进行I期临床试验来支持这一开发。进入SBIR计划第二阶段的具体里程碑将是允许IND在2003年底之前招收第一名患者。 该工作计划将发展进程从该项目于2003年3月开始，推进到IND津贴，估计大约在2003年10月30日发生。在此期间要实现的具体目标包括1)进行临床前安全性和毒理学研究，2)临床方案和现场开发，3)生产GMP产品，4)临床前分析性测试计划和分析开发，以及5)开发支持临床试验所需的临床免疫原性分析。

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.