Development of a Cytomegalovirus DNA Vaccine

巨细胞病毒 DNA 疫苗的开发

• 批准号: 6736621
• 负责人: Thomas G Evans
• 金额: $ 26.38万
• 依托单位: VICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-02-01 至 2004-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6736621
• 关键词: clinical research; cytomegalovirus; experimental designs; human subject; immunologic assay /test; laboratory mouse; laboratory rat; plasmids; vaccine development; vaccine evaluation; vector vaccine; viral vaccines

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.

描述（由申请人提供）：Vical Incorporated 的这一 I 期 SBIR 提案的具体目标是推动巨细胞病毒 (CMV) 免疫治疗疫苗从临床前开发到临床开发。 Vical 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发生 CMV 病毒血症、疾病和相关并发症。该疫苗是一种二价构建体，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。该 SBIR 提案将支持临床前安全性研究、检测开发、制造和人类 I 期临床试验规划的最后阶段的开发。进入 SBIR 计划第二阶段的具体里程碑将是允许 IND 准备在 2003 年底前招募第一位患者。 该工作计划将开发过程从该项目 3 月 3 日开始一直持续到 IND 许可，预计大约在 2003 年 10 月 30 日进行。在此期间要实现的具体目标（部分由第一阶段 SBIR 申请资助）包括 1) 进行临床前安全性和毒理学研究，2) 临床方案和场地开发，3) GMP 产品的制造，4) 临床前分析测试计划和测定开发，以及 5) 开发支持临床试验所需的临床免疫原性测定。