NCT06075745

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Liver Transplant

Interventions

Type	Name	Description
DRUG	CMV-MVA Triplex	The dosage used will be 5.0 x 10\^8 pfu, administered under sterile conditions intramuscularly. The CMV-MVA Triplex vaccine lots range in titre from 5.0 to 9.0 x 10\^8 pfu/mL in a supplied volume of 1.0 mL
DRUG	Placebo for CMV-MVA Triplex	Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex

Timeline

• Start date: 2024-03-05
• Primary completion: 2027-06-30
• Completion: 2028-02-28
• First posted: 2023-10-10
• Last updated: 2026-04-02

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study