Could a vaccine before liver transplant cut antiviral use?
NCT ID NCT06075745
First seen Jun 24, 2026 · Last updated Sep 17, 2026 · Updated 6 times
Summary
This phase 2 trial tests a CMV vaccine (CMV-MVA Triplex) given before a liver transplant to see if it reduces the need for antiviral drugs after surgery. The study enrolls 416 CMV-negative adults awaiting a liver transplant from a CMV-positive donor. Participants receive two vaccine doses or a placebo before transplant, and researchers track antiviral use and side effects for 100 days after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CMV-MVA Triplex vaccine
- What this could lead to
- If successful, this vaccine could reduce the need for strong antiviral drugs after a liver transplant, lowering side effects and improving recovery.
- What could go wrong
- This is a phase 2 trial, so it's still early. The vaccine may not work as hoped, and side effects like injection site pain or fever are possible. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 416 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject must be able to understand and provide informed consent 2. 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) 3. Negative human immunodeficiency virus (HIV) testing and no clinical suspicion of HIV infection 4. Planned for a first living donor liver transplant or listed/anticipated to be listed for a first deceased donor liver transplant. 5. Anticipated to receive a liver transplant within 1-12 months 6. 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) 7. 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) 8. 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: 1. 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 2. For women of reproductive potential as defined previously, a negative serum or urine pregnancy test (performed within 72 hours) Exclusion Criteria: 1. Women who are breastfeeding or planning to breastfeed 2. Prior Cytomegalovirus (CMV) vaccination 3. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes coronavirus disease (COVID) convalescent plasma) 4. Currently enrolled in another interventional study that, in the investigator's opinion, could affect the evaluation of safety and/or vaccine effect outcomes 5. Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.) 6. 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) 7. Transplant status 1A or in the opinion of the investigator is likely to receive a transplant within the next month 8. At the time of randomization, either listed for, or, in the opinion of the investigator, likely to receive any non-liver organ transplant 9. Receipt of a clinical vaccine \< 14 days before or planned to receive a clinical vaccine \<14 days after the study agent 10. Known allergy to any component of the study agent 11. 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: 1. Anaphylaxis or other severe reaction (Grade 4) considered definitely or probably attributable to dose 1 2. Receipt of liver transplant prior to dose 2 3. 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 4. Receipt of a clinical vaccine \< 14 days before or planned to receive a clinical vaccine \<14 days after the study agent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University School of Medicine
RECRUITINGDurham, North Carolina, 27710-1000, United States
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Emory University Hospital
ACTIVE_NOT_RECRUITINGAtlanta, Georgia, 30322-0000, United States
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Johns Hopkins University School of Medicine
RECRUITINGBaltimore, Maryland, 21205-0000, United States
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Mayo Clinic, Rochester - College of Medicine and Science
RECRUITINGRochester, Minnesota, 55905-0001, United States
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Northwestern University, Feinberg School of Medicine
RECRUITINGChicago, Illinois, 60611-0000, United States
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Oregon Health & Sciences University
RECRUITINGPortland, Oregon, 97239-3098, United States
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Stanford University
RECRUITINGRedwood City, California, 94063-3126, United States
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University of Alabama at Birmingham, School of Medicine
WITHDRAWNBirmingham, Alabama, 35233, United States
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University of California, San Diego School of Medicine
RECRUITINGLa Jolla, California, 92093, United States
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University of California, San Francisco
RECRUITINGSan Francisco, California, 94143-0000, United States
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University of Miami, Jackson Memorial Hospital
RECRUITINGMiami, Florida, 33136-1003, United States
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University of Michigan Medical Center
RECRUITINGAnn Arbor, Michigan, 48109-1274, United States
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198-7835, United States
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University of Pennsylvania School of Medicine
RECRUITINGPhiladelphia, Pennsylvania, 19104-5127, United States
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University of Pittsburgh Medical Center
RECRUITINGPittsburgh, Pennsylvania, 15213-0000, United States
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University of Texas Southwestern Medical Center
RECRUITINGDallas, Texas, 75390-0000, United States
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University of Washington Medical Center: Transplantation
RECRUITINGSeattle, Washington, 98195, United States
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Vanderbilt University School of Medicine
RECRUITINGNashville, Tennessee, 37232-0011, United States
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