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.
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
Severe active infection, compromised cardiopulmonary function, or other serious medical illness that, in the opinion of the principal investigator, would prevent study completion
History of chronic active EBV infection, active infectious mononucleosis (or infectious mononucleosis within 6 months of enrollment), or other EBV-related disorder as determined by principal investigator (PI)
History of immune suppression or autoimmune disorder
Concomitant use of systemic corticosteroids or other immunosuppressive medications (including nasal and inhaled steroids). The use of nasal steroids for seasonal rhinitis is acceptable