Stopped: study drug issue
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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Incidence of treatment-emergent adverse events
Timeframe: From the first administration of treatment until the week 28 visit
Changes in laboratory parameters and vital signs
Timeframe: At baseline and up to week 56
Pre- and post-injection vital signs
Timeframe: Up to week 4
Injection site reactions
Timeframe: At 10 and/or 60 minutes post injection on weeks 0, 2 and 4