MUCOSAL IMMUNITY & REPLICATION OF HUMAN CYTOMEGALOVIRUS

粘膜免疫

• 批准号: 6335438
• 负责人: GEORGE W KEMBLE
• 金额: $ 26.71万
• 依托单位: MEDIMMUNE VACCINES, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2001-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6335438
• 关键词: Herpesviridae vaccine; attenuated microorganism; clinical research; clinical trial phase I; cytomegalovirus; host organism interaction; human subject; immunoglobulin A; immunoglobulin G; immunologic assay /test; live vaccine; mucosal immunity; polymerase chain reaction; recombinant virus; vaccine development; virus replication

Human cytomegalovirus (HCMV) associated disease is responsible for over $10 billion in healthcare costs annually in the US. Mental retardation and hearing impairment caused by congenital CMV infection, and organ transplant rejection and MDS associated CMV retinitis and colitis are preventable diseases. However, no vaccine currently exists for prevention of HCMV disease and most inactivated or subunit approaches have failed. Aviron's objective is to develop a safe, live, attenuated HCMV vaccine for universal childhood immunization. Vaccination of seronegative persons prior to immunosuppression for organ transplantation or HIV infection may also prevent the morbidity and mortality of severe HCMV disease in the immunocompromised host. The goal of the research proposed in the Phase l SBIR application is to apply recent innovative advances in mucoaal vaccine delivery and virus detection to understand the human host's response to acute CMV infection and immunization. These data will be used to determine if a set of four specifically designed, reombinant, live HCMV vaccine candidates when delivered to the naso-, oral mucosal surface elicits humoral and cell-based responses that are likely to provide protection from the sequelae of HCMV infection. PROPOSED COMMERCIAL APPLICATIONS: An effective, live attenuated HCMV vaccine should prevent mental retardation and hearing impairment associated with HCMV congenital disease. There are no preventative or therapeutic regimens available to reduce HCMV congenital disease, therefore, the live HCMV vaccine addresses an unmet public health

人类巨细胞病毒(HCMV)相关疾病在美国每年造成超过100亿美元的医疗费用。先天性巨细胞病毒感染引起的智力低下和听力障碍，器官移植排斥反应和MDS相关性巨细胞病毒视网膜炎和结肠炎是可以预防的疾病。然而，目前还没有预防巨细胞病毒病的疫苗，大多数灭活或亚单位方法都失败了。Aviron的目标是开发一种安全、活的、减毒的HCMV疫苗，用于普及儿童免疫。在器官移植或艾滋病毒感染的免疫抑制之前为血清阴性者接种疫苗，也可以防止免疫受损宿主中严重的HCMV病的发病率和死亡率。在L SBIR应用阶段提出的这项研究的目标是应用粘膜疫苗交付和病毒检测方面的最新创新进展，以了解人类宿主对急性巨细胞病毒感染和免疫的反应。这些数据将被用来确定一套由四种特定设计的重组活HCMV疫苗接种到鼻腔、口腔粘膜表面时是否会引起体液和细胞反应，从而可能提供保护，防止HCMV感染的后遗症。拟议的商业应用：一种有效的减毒活疫苗应该可以预防与巨细胞病毒先天疾病相关的智力低下和听力障碍。目前尚无预防或治疗方案可用于减少巨细胞病毒先天性疾病，因此，巨细胞病毒活疫苗解决了一个未得到满足的公共卫生问题。