Actively Recruiting
Phase 2 Study of CMV-MVA Triplex Vaccine in HLA-Matched Related Stem Cell Donors to Prevent CMV Infection in Patients Undergoing Stem Cell Transplant
Led by City of Hope Medical Center · Updated on 2026-03-10
216
Participants Needed
3
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the CMV-MVA Triplex vaccine in a phase II clinical trial to see how well it helps prevent cytomegalovirus CMV infection in patients receiving hematopoietic stem cell transplants from related donors who are a close human leukocyte antigen HLA match. The vaccine is designed to trigger an immune response against CMV in the stem cell donors, which may then be passed on to the patients through the transplant, possibly helping to reduce CMV infection after transplantation. The study also aims to evaluate the vaccines safety and its impact on CMV-related events and transplant outcomes. Donors in the trial are randomly assigned to receive either the Triplex vaccine or a placebo by intramuscular injection on day 0. Following vaccination, donors undergo stem cell mobilization with granulocyte colony-stimulating factor G-CSF between days 5 and 9, and peripheral blood stem cell collection by apheresis between days 10 and 14. Recipients receive pre-transplant conditioning within 60 days before the transplant and then undergo hematopoietic stem cell transplantation with donor cells within nine weeks of donor vaccination. After treatment, donors and recipients have scheduled follow-up visits to monitor health and immune responses. Participants undergo various assessments including blood sample collections to monitor CMV infection and immune function. Recipients are followed closely for up to one year after transplant at multiple time points to evaluate CMV disease occurrence, use of antiviral treatment, transplant-related events, and overall safety. Donors have follow-up visits up to one year after vaccination to assess adverse events. The trial measures outcomes such as time to CMV disease or treatment, incidence of graft-versus-host disease, mortality rates, and immune response levels to understand the vaccines effects and safety over time.
CONDITIONS
Brief Title
CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant
Research Team
V
Vaibhav Agrawal, MD
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