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

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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.