Phase 1B Study of OSU-2131 BZLF1 Peptide Vaccine With QS-21 to Prevent Epstein-Barr Virus and Related Cancers in Healthy Adults and Patients Awaiting Organ Transplant

What this Trial Is About

Researchers are evaluating a vaccine called OSU-2131 combined with QS-21 to prevent Epstein-Barr virus EBV infection and related cancers in healthy volunteers and patients awaiting solid organ transplants. This phase 1B trial aims to test the safety, side effects, and best dose of this vaccine while studying how well it helps the immune system fight EBV. Patients awaiting organ transplants often receive immune suppression therapy, which raises their risk of EBV-related cancers, so this vaccine may provide protection during that vulnerable time. Participants receive one of two treatments either OSU-2131 vaccine with QS-21 or a placebo phosphate-buffered saline. The vaccine or placebo is given by subcutaneous injection on day 0, and again at weeks 2 and 4, as long as no unacceptable side effects occur or the patient proceeds to transplant. Blood samples are taken throughout the study to monitor immune responses. The study includes a dose-escalation phase followed by dose expansion to find the optimal dose for safety and immune response. Participants are monitored closely with blood tests and vital sign checks at multiple time points up to 56 weeks after the first dose. Researchers measure adverse events, laboratory parameters, injection site reactions, and immune responses to evaluate safety and effectiveness. Follow-up visits occur at days 29 and 35, then at 6, 16, 28, 40, and 56 weeks. The total study period allows detailed monitoring of how the vaccine affects participants over time.

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