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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
416
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
Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex
University of Alabama at Birmingham, School of Medicine
Birmingham, Alabama, United States
WITHDRAWNUniversity of California, San Diego School of Medicine
La Jolla, California, United States
RECRUITINGStanford University
Redwood City, California, United States
RECRUITINGUniversity of California, San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Miami, Jackson Memorial Hospital
Miami, Florida, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGNorthwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
RECRUITINGJohns Hopkins University School of Medicine
Baltimore, Maryland, United States
RECRUITINGUniversity of Michigan Medical Center
Ann Arbor, Michigan, United States
RECRUITINGMayo Clinic, Rochester - College of Medicine and Science
Rochester, Minnesota, United States
RECRUITING...and 8 more locations
Total days of Cytomegalovirus (CMV) active antiviral therapy (AVT) in CMV seropositive donor (D+) and seronegative (R-) and (D+R-) liver transplant recipients
Time frame: Within the first 100 days post-transplantation
Percent of participants with solicited adverse reactions
Consisting of local reactions including: injection site pain, swelling, erythema (redness); systemic reactions: fever, headache, muscle ache, fatigue)
Time frame: Within 7 days of each dose
Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)
Time frame: Within 100 days after initial dose
Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)
Time frame: Within 28 days after each dose
Percent of participants with pre-transplant treatment emergent adverse events (TEAE)
Grade \>=3 severity or increase of severity of baseline abnormality that results in grade \>= 3 severity
Time frame: Within 28 days after each dose
Percent of participants with treatment emergent serious adverse events (TESAE)
Grade \>= 4 severity
Time frame: Throughout the study
Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop Endpoint-Committee adjudicated Cytomegalovirus (CMV) disease
Time frame: By 6 months post-transplant (Tx)
Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop investigator-reported Cytomegalovirus (CMV) disease
Time frame: By 6 months post-transplant (Tx)
Time to onset of Endpoint-Committee adjudicated Cytomegalovirus (CMV) disease in seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients
Time frame: By 6 months post-transplant (Tx)
Time to onset of Endpoint-Committee adjudicated Cytomegalovirus (CMV) in seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients
Time frame: By 6 months post-transplant (Tx)
Time to onset of investigator-reported Cytomegalovirus (CMV) disease
Time frame: By 6 months post-transplant (Tx)
Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop CMV DNAemia >= 1000 IU/mL
Time frame: Within first 100 days post-transplant (Tx)
Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop Endpoint committee adjudicated CMV disease
Time frame: Within first 100 days post-transplant (Tx)
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