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

目的：评价金丝雀痘ALVAC-CMV(VCP260)的安全性。 猪瘟Towne株pp65基质蛋白的重组编码 人类巨细胞病毒。Pp65特异性T辅助细胞的诱导， 细胞毒性T淋巴细胞，体液免疫反应也会 评估过了。 到目前为止：对33名患者进行了资格筛选。这项研究需要5个人 CMV血清阳性患者和25名CMV血清阴性患者完成 招生。筛查将继续进行，直到我们有另外7个CMV 血清阴性受试者。预计筛查工作将于年中完成 1998年2月。 12名受试者(2组，1名血清阳性，5名 每组血清阴性受试者)。这12名受试者已经接受了2剂 并计划在2月份进行第三次接种。一直没有 与研究疫苗相关的严重不良事件。前两个 小组将于1998年11月完成这项研究。 下一批6人将在2月初登记参加第一剂疫苗，以及 将于1999年2月完成这项研究。 我们预计在未来几个月内招收最后两个小组，这两个小组 将可在1999年4月完成这项研究。

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.