CLINICAL TRIALS OF A GENETICALLY ENGINEERED HCMV

基因工程 HCMV 的临床试验

• 批准号: 2887366
• 负责人: GEORGE W KEMBLE
• 金额: $ 2万
• 依托单位: MEDIMMUNE VACCINES, INC.
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-06-01 至 2000-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2887366
• 关键词: Herpesviridae vaccine; attenuated microorganism; clinical research; clinical trials; cytomegalovirus; human subject; human therapy evaluation; live vaccine; nucleic acid sequence; plasmids; polymerase chain reaction; recombinant virus; vaccine development; vector vaccine; virulence; virus genetics

DESCRIPTION: (Adapted from the applicant's abstract) Human cytomegalovirus (HCMV) is the most common viral infection known to be transmitted in utero. Congenital infection with HCMV is the leading cause of deafness and can result in death or major neurodevelopmental defects including chorioretinitis and mental retardation. The disease burden due to HCMV currently exceeds that occurring during the height of the epidemic rubella era. HCMV also produces life threatening sequelae in persons who are immunocompromised by drug therapy for transplantation, cancer treatment, or who have HIV infection. Aviron proposes to develop a live attenuated vaccine for the prevention of disease caused by HCMV. They successfully developed molecular genetic processes to engineer HCMV. Using a Phase I SBIR grant, they generated a well-defined series of five recombinant HCMV vaccine candidates. Each candidate contains genetically stable portions of the nonattenuated Toledo HCMV viral genome within a background of the safe, overattenuated Towne HCMV genome. In Phase II of the SBIR program, they propose to produce two of the five chimeras for human testing and determine their safety and immunogenicity in a Phase I clinical trial in collaboration with the NIH VTEU network. Their goal is to select a vaccine strain based on the human data for final commercial development. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

描述：(改编自申请人的摘要)人类 巨细胞病毒(HCMV)是已知最常见的病毒感染 在子宫内传播。先天性巨细胞病毒感染是主要原因 耳聋，会导致死亡或严重的神经发育缺陷 包括脉络膜视网膜炎和智力低下。应承担的疾病负担 目前超过了疫情高峰期的情况 风疹时代。人巨细胞病毒也会在以下患者中产生威胁生命的后遗症 移植、癌症的药物治疗会损害免疫功能吗？ 治疗，或谁感染了艾滋病毒。 Aviron建议开发一种减毒活疫苗，以预防 由人巨细胞病毒引起的疾病。他们成功地开发出了分子遗传学 工程人巨细胞病毒的流程。使用第一阶段SBIR赠款，他们产生了一个 明确的五种重组人巨细胞病毒候选疫苗系列。每个人 候选包含未减毒的托莱多的遗传稳定部分 背景中的HCMV病毒基因组是安全、过度减毒的汤尼 人巨细胞病毒基因组。在SBIR计划的第二阶段，他们提议生产两个 用于人体测试的五个嵌合体，并确定它们的安全性和 与美国国立卫生研究院合作的一项I期临床试验的免疫原性 VTEU网络。他们的目标是选择一种基于人类的疫苗株 最终商业开发的数据。 建议的商业应用：不可用