BZLF1 Peptide Vaccine (OSU-2131) With QS-21 for the Prevention of Epstein-Barr Virus Related Cancer in Patients Awaiting Solid Organ Transplants

PRIMARY OBJECTIVE: I. Determine the overall safety profile of three different dose levels of OSU-2131 vaccination each with 50 mcg Stimulon (Trademark) Quillaja saponin (QS)-21 Solution adjuvant (QS-21), wherein the OSU-2131 doses are 80, 240 and 480 mcg in healthy volunteers and similar safety profile of the identified maximum tolerated dose (MTD) in patients awaiting solid organ transplantation. SECONDARY OBJECTIVES: I. Determine the optimal immunologic dose (OID) to OSU-2131 vaccination (with QS-21) in all dose cohorts of 80, 240, and 480 mcg OSU-2131 (healthy volunteers) and, upon completing safety assessment, patients awaiting solid organ transplant (PASOT). II. To perform laboratory correlative studies to examine immune responses to the OSU-2131 vaccine with the intent to communicate the research results and to generate a de-identified data set that can then be used for future comparisons with immune response data generated in future vaccine trials. OUTLINE: This is a dose-escalation study of OSU-2131 with fixed-dose QS-21 followed by a dose-expansion study. Healthy volunteers are randomized to 1 of 2 groups. Patients awaiting a solid organ transplant are assigned to Group I. GROUP I (OSU-2131 WITH QS-21): Healthy volunteers and patients receive OSU-2131 subcutaneously (SC) with QS-21 SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity or patient proceeds to transplant. Healthy volunteers and patients additionally undergo blood sample collection throughout the study. GROUP II (PLACEBO): Healthy volunteers receive Dulbecco's phosphate-buffered saline (phosphate buffered saline \[PBS\]) SC on day 0, and weeks 2 and 4 in the absence of unacceptable toxicity. Healthy volunteers additionally undergo blood sample collection throughout the study. After completion of study intervention, healthy volunteers and patients are followed up at days 29 and 35 and then at 6, 16, 28, 40 and 56 weeks.