Study of Two Doses of CMV-MVA Triplex Vaccine in Adults Awaiting First Liver Transplant to Reduce Cytomegalovirus Infection

What this Trial Is About

Researchers are evaluating the efficacy of two doses of the Cytomegalovirus-Modified Vaccinia Ankara CMV-MVA Triplex vaccine given before liver transplantation in adults who are CMV seronegative and awaiting their first liver transplant. The study focuses on whether this vaccination can reduce the duration of antiviral therapy needed for CMV within the first 100 days after transplant in recipients who receive a liver from a CMV seropositive donor. A preemptive therapy approach will be used to prevent CMV disease in these transplant recipients. Participants will be randomly assigned to receive either two doses of the CMV-MVA Triplex vaccine or two doses of a matching placebo before transplantation. The vaccine is administered as an intramuscular injection, with each dose containing 5.0 x 108 plaque-forming units in a 1.0 mL volume. The study uses a parallel design with double blinding to compare the vaccine and placebo groups. During the study, participants will be monitored for CMV antiviral therapy use, adverse reactions within 7 days after each dose, and serious adverse events up to 100 days after the first dose. Researchers will also assess the development of CMV disease and viral levels up to 6 months post-transplant. Regular assessments and laboratory tests will be conducted to track safety, efficacy, and immune response throughout the study period ending in February 2028.

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates