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Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

NCT06075745 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 416

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ajit P Limaye, MD · University of California, San Francisco: Transplantation

  • Cindy Fisher, M.D. · University of Washington Medical Center: Transplantation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2027-06-30
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06075745 on ClinicalTrials.gov