SAFETY AND IMMUNOGENICITY OF CANARYPOX CMV (VCP260) IN HEALTHY ADULTS

金丝雀痘 CMV (VCP260) 对健康成年人的安全性和免疫原性

• 批准号: 6116902
• 负责人: Stuart E Starr
• 金额: $ 2.47万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6116902
• 关键词: Poxviridae; adult human (21+); clinical research; cytomegalovirus; drug adverse effect; drug screening /evaluation; human subject; human therapy evaluation; humoral immunity; outcomes research; recombinant virus; viral vaccines

Objective: To evaluate the safety of ALVAC-CMV (vCP260), a canarypox recombinant coding for the pp65 matrix protein of the Towne strain of human cytomegalovirus. The induction of pp65-specific T helper cells, cytotoxic T lymphocytes, and humoral immune response will also be assessed. To Date: 33 patients were screened for eligibility. The study requires 5 CMV seropositive subjects and 25 CMV seronegative subjects for complete enrollment. Screening will continue until we have 7 additional CMV seronegative subjects. Screening is expected to be completed by mid February 1998. 12 subjects have been enrolled (2 groups with 1 seropositive and 5 seronegative subjects per group). These 12 subjects have received 2 doses and are scheduled for their 3rd dose in February. There have been no serious Adverse Events associated with the study vaccine. The first two groups will complete the study in November 1998. The next group of 6 will be enrolled in early February for dose 1, and will complete the study in February, 1999. We expect to enroll the last 2 groups within the next few months, which will allow completion of the study by April, 1999.

目的：评价金丝雀痘病毒ALVAC CMV（vCP 260）的安全性 编码大肠杆菌Towne株的pp 65基质蛋白的重组体 人巨细胞病毒pp 65特异性T辅助细胞的诱导， 细胞毒性T淋巴细胞和体液免疫反应也将是 评估。 迄今为止：筛选了33例患者的合格性。研究需要5 CMV血清阳性受试者和25例CMV血清阴性受试者， 招生 筛查将继续，直到我们有7个额外的CMV 血清阴性受试者。筛选预计将于2015年12月31日完成。 1998年2月 入组了12例受试者（2组，1例血清阳性，5例 血清阴性受试者/组）。这12例受试者接受了2剂 并计划在二月进行第三次注射没有发生 与研究疫苗相关的严重不良事件。前两 研究将于一九九八年十一月完成。 下一组6人将于2月初入组接受第1剂， 研究将于一九九九年二月完成。 我们预计在未来几个月内招募最后两组， 研究可于一九九九年四月完成。