Clinical Trial

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Study acronym: COLT
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2023-10-04; most recent amendment 2026-07-22.
Status change: Not Yet Recruiting → Recruiting 2024-04-12
Trial Details
NCT Number NCT06075745
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Conditions Liver Transplant
Enrollment 416 participants
Start Date 2024-03-05
Primary Completion 2027-06-30 (estimated)
Study Completion 2028-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-24