Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Liver Transplant

In brief

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.

Key facts

Study ID: NCT06075745
Run by: National Institute of Allergy and Infectious Diseases (NIAID)
People needed: 416
Starts: 2024-03-05
Expected to finish: 2028-02-28
Last updated by the study team: 2026-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject must be able to understand and provide informed consent
Negative for Cytomegalovirus (CMV) IgG antibody as assessed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory within 12 months of enrollment, and no history of prior positive CMV serology (IgG antibody)
Negative human immunodeficiency virus (HIV) testing and no clinical suspicion of HIV infection
Planned for a first living donor liver transplant or listed/anticipated to be listed for a first deceased donor liver transplant.
Anticipated to receive a liver transplant within 1-12 months
For individuals of reproductive potential, a negative serum or urine pregnancy test within 72 hours prior to enrollment. NOTE: Individuals of reproductive potential are defined as individuals who have reached menarche and who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) >=40 IU/mL or 24 consecutive months if an FSH is not available, i.e., who have had menses within the preceding 24 months, and have not undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, or salpingectomy)
Participants who are able to impregnate or become pregnant (i.e., of reproductive potential) and are participating in sexual activity that could lead to pregnancy must agree to practice contraception/birth control (hormonal or barrier method) or agree to not participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for at least 1 month following the last vaccine/placebo dose. For acceptable contraception methods that are more than 80 percent effective, see Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol)
The most recent platelet count is >= 20,000 cells/mm\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased < 20,000 cells/mm\^3 at time of study IP administration.
Eligibility criteria required: Dose 2:
Most recent platelet count >= 20,000 cells/mm\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased < 20,000 cells/mm\^3 since last result
For women of reproductive potential as defined previously, a negative serum or urine pregnancy test (performed within 72 hours)

You may not qualify if…

Women who are breastfeeding or planning to breastfeed
Prior Cytomegalovirus (CMV) vaccination
Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes coronavirus disease (COVID) convalescent plasma)
Currently enrolled in another interventional study that, in the investigator's opinion, could affect the evaluation of safety and/or vaccine effect outcomes
Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.)
Receipt of immunosuppression:
Within the last 3 months prior to randomization:
Systemic Chemotherapy or immunotherapy for cancer in the last 3 months (localized therapy for hepatocellular carcinoma [HCC] such as chemoembolization, Y-90 are not considered "systemic chemotherapy" and are not excluded)
Systemic immunosuppressive agents (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, mTOR inhibitors, TNF-alpha inhibitors) and/or combination immunosuppressive drugs for any autoimmune or other conditions in the last 3 months except corticosteroids as below
Within the last 28 days prior to randomization: averaged daily corticosteroid therapy dose ≥20 mg of prednisone equivalent
Within the last 6 months prior to randomization: receipt of T- or Bcell depleting agents (e.g. ATG, Alemtuzumab, Rituximab)
Transplant status 1A or in the opinion of the investigator is likely to receive a transplant within the next month
At the time of randomization, either listed for, or, in the opinion of the investigator, likely to receive any non-liver organ transplant
Receipt of a clinical vaccine < 14 days before or planned to receive a clinical vaccine <14 days after the study agent
Known allergy to any component of the study agent
Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
Exclusion criteria required: Dose 2:
Anaphylaxis or other severe reaction (Grade 4) considered definitely or probably attributable to dose 1
Receipt of liver transplant prior to dose 2
The participant must not have any severe acute illness or other factor, that, in the opinion of the investigator, requires postponement of dose 2 because of safety concerns. The participant can be re-evaluated for eligibility throughout the window of eligibility for the dose 2, once the illness or other factor has improved or resolved
Receipt of a clinical vaccine < 14 days before or planned to receive a clinical vaccine <14 days after the study agent

Where it is running

University of Washington Medical Center: Transplantation — Seattle, Washington, United States (enrolling)
University of California, San Diego School of Medicine — La Jolla, California, United States (enrolling)
Stanford University — Redwood City, California, United States (enrolling)
University of California, San Francisco — San Francisco, California, United States (enrolling)
University of Miami, Jackson Memorial Hospital — Miami, Florida, United States (enrolling)
Emory University Hospital — Atlanta, Georgia, United States (enrolling)
Northwestern University, Feinberg School of Medicine — Chicago, Illinois, United States (enrolling)
Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (enrolling)
University of Michigan Medical Center — Ann Arbor, Michigan, United States (enrolling)
Mayo Clinic, Rochester - College of Medicine and Science — Rochester, Minnesota, United States (enrolling)
University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
Duke University School of Medicine — Durham, North Carolina, United States (enrolling)
Oregon Health & Sciences University — Portland, Oregon, United States (enrolling)
University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
Vanderbilt University School of Medicine — Nashville, Tennessee, United States (enrolling)
University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
University of Alabama at Birmingham, School of Medicine — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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