CLINICAL TRIALS OF A GENETICALLY ENGINEERED HCMV

基因工程 HCMV 的临床试验

• 批准号: 2879284
• 负责人: GEORGE W KEMBLE
• 金额: $ 20万
• 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/2879284
• 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：（改编自申请人摘要）人 巨细胞病毒（HCMV）是已知的最常见的病毒感染， 在子宫内传播先天性巨细胞病毒感染是主要原因 耳聋，并可能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迟钝。 疾病负担 目前HCMV感染率超过了流行高峰期 风疹时代。 HCMV还可在以下人群中产生危及生命的后遗症： 由于移植、癌症等药物治疗， 治疗，或有艾滋病毒感染者。 阿维龙建议开发一种减毒活疫苗，用于预防 由HCMV引起的疾病 他们成功开发了分子遗传学 制造HCMV的过程。 使用第一阶段SBIR赠款，他们产生了一个 明确定义的五种重组HCMV候选疫苗系列。 每个 候选物含有非减毒Toledo的遗传稳定部分 安全、过减毒Towne背景下的HCMV病毒基因组 HCMV基因组。 在SBIR计划的第二阶段，他们建议生产两个 五个嵌合体进行人体测试，并确定其安全性， 与NIH合作的I期临床试验中的免疫原性 VTEU网络。 他们的目标是选择一种疫苗株， 最终商业开发的数据。 拟议商业应用：不可用