drugset / Trial / NCT06075745
Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multi-center clinical trial in Cytomegalovirus (CMV) seronegative prospective liver transplant recipients to determine the efficacy of two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant. The primary objective is to assess the effect of pre-transplant (Tx) Triplex vaccination on duration of CMV antiviral therapy (AVT) within the first 100 days post-Tx in CMV seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients (LTxRs). A protocol-mandated preemptive therapy (PET) will be used for CMV disease prevention in D+R- LTxRs.
Timeline
- Start
- 2024-03-05
- Primary completion
- 2027-06-30
- Completion
- 2028-02-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CMV-MVA Triplex | Vaccine | 5e+08 unknown | Intramuscular |
Indications
No indication recorded.