RecruitingPhase 2NCT06075745

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

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

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

416 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

Liver Transplant

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This multi-center trial tests whether a vaccine called CMV-MVA Triplex, given before a liver transplant, can reduce how much antiviral medication patients need after transplant to prevent cytomegalovirus (CMV) — a common and potentially dangerous viral infection in transplant patients. The vaccine is given twice before surgery to people who have never been infected with CMV but are receiving a liver from a CMV-positive donor, a combination that puts them at highest risk. Adults who are CMV-negative, HIV-negative, and are listed for or expected to receive a first liver transplant within 1–12 months may be eligible. Participation involves two pre-transplant vaccine or placebo injections and monitoring of CMV levels and antiviral treatment use in the 100 days after transplant. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCMV-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

DRUGPlacebo for CMV-MVA Triplex

Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex

Locations(18)

University of Alabama at Birmingham, School of Medicine

Birmingham, Alabama, United States

University of California, San Diego School of Medicine

La Jolla, California, United States

Stanford University

Redwood City, California, United States

University of California, San Francisco

San Francisco, California, United States

University of Miami, Jackson Memorial Hospital

Miami, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Mayo Clinic, Rochester - College of Medicine and Science

Rochester, Minnesota, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Duke University School of Medicine

Durham, North Carolina, United States

Oregon Health & Sciences University

Portland, Oregon, United States

University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

University of Washington Medical Center: Transplantation

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06075745

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