Development of a Cytomegalovirus DNA Vaccine

描述（由申请人提供）：Vical Incorporated的这一I期SBIR提案的具体目的是将巨细胞病毒（CMV）免疫抑制疫苗从临床前开发推进到临床开发。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。该疫苗是编码蛋白质g B和pp65的修饰基因的二价构建体，并配制在泊洛沙姆CRL 1005中以增强B和T细胞应答。该SBIR提案将支持该开发，直至临床前安全性研究、检测试剂盒开发、生产和人体I期临床试验计划的最后阶段。进入SBIR项目II期的具体里程碑将是允许IND在2003年底前准备招募第一例患者。 工作计划将开发过程从2003年3月的项目点推进到IND许可，预计将在2003年10月30日左右发生。在此期间要实现的具体目标（部分由该I期SBIR申请资助）包括：1）进行临床前安全性和毒理学研究，2）临床方案和研究中心开发，3）GMP产品生产，4）临床前分析检测计划和检测开发，以及5）开发支持临床试验所需的临床免疫原性检测。

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.