Could a vaccine before liver transplant cut antiviral use?

NCT ID NCT06075745

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 416 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Duke University School of Medicine

    RECRUITING

    Durham, North Carolina, 27710-1000, United States

  • Emory University Hospital

    ACTIVE_NOT_RECRUITING

    Atlanta, Georgia, 30322-0000, United States

  • Johns Hopkins University School of Medicine

    RECRUITING

    Baltimore, Maryland, 21205-0000, United States

  • Mayo Clinic, Rochester - College of Medicine and Science

    RECRUITING

    Rochester, Minnesota, 55905-0001, United States

  • Northwestern University, Feinberg School of Medicine

    RECRUITING

    Chicago, Illinois, 60611-0000, United States

  • Oregon Health & Sciences University

    RECRUITING

    Portland, Oregon, 97239-3098, United States

  • Stanford University

    RECRUITING

    Redwood City, California, 94063-3126, United States

  • University of Alabama at Birmingham, School of Medicine

    WITHDRAWN

    Birmingham, Alabama, 35233, United States

  • University of California, San Diego School of Medicine

    RECRUITING

    La Jolla, California, 92093, United States

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94143-0000, United States

  • University of Miami, Jackson Memorial Hospital

    RECRUITING

    Miami, Florida, 33136-1003, United States

  • University of Michigan Medical Center

    RECRUITING

    Ann Arbor, Michigan, 48109-1274, United States

  • University of Nebraska Medical Center

    RECRUITING

    Omaha, Nebraska, 68198-7835, United States

  • University of Pennsylvania School of Medicine

    RECRUITING

    Philadelphia, Pennsylvania, 19104-5127, United States

  • University of Pittsburgh Medical Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15213-0000, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390-0000, United States

  • University of Washington Medical Center: Transplantation

    RECRUITING

    Seattle, Washington, 98195, United States

  • Vanderbilt University School of Medicine

    RECRUITING

    Nashville, Tennessee, 37232-0011, United States

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