Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) • ClinicalTrials.gov ID: NCT06075745
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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.
Interventions
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CMV-MVA Triplex
(Drug)
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
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Placebo for CMV-MVA Triplex
(Drug)
Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex
Eligibility criteria
Conditions
Locations
- 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
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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