Ohio State University Comprehensive Cancer Center
This phase 1B trial tests the safety, side effects and best dose of rh-Hsc70- BZLF1 peptide complex (OSU-2131) with Stimulon (Trademark) QS-21 and evaluates how well it works in preventing Epstein-Barr virus (EBV) infection and related cancers in healthy volunteers and patients awaiting a solid organ transplant. Currently, patients who receive an organ transplant receive immune suppression therapy which can make it harder for the body to fight infections. This treatment also increases the risk for cancers that are triggered by the EBV. Vaccines made from synthetic peptide (RAKFKQLL) derived from the BZLF1 protein, may help the body build an effective immune response against EBV infections. QS-21, a saponin adjuvant, is a substance from plants that, when given with vaccine therapy, may improve the way the immune system responds to disease. Giving OSU-2131 with QS-21 may help the immune system fight EBV and protect against EBV infection and the cancers that it can cause 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 compl…
Inclusion Criteria: * Healthy volunteers and patients awaiting solid organ transplantation (SOT) must have at least one allele for HLA-B\*08:01 * Subjects can be Epstein-Barr virus (EBV) seronegative or seropositive * Subjects must be seronegative for HIV * Subjects must be seronegative for hepatitis B and C * Have baseline chemistry and hematology (hemoglobin, white blood cells, absolute neutrophil count, eosinophils) within normal limits * Prothrombin time (PT) and partial thromboplastin time (PTT) below the upper limit of normal * Platelets above the lower limit of normal (LLN) * Basophils…
Undergo blood sample collection
Given SC
Given OSU-2131 SC
Given SC