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CMV Vaccine for Liver Transplant Candidates

This study is testing a vaccine called CMV-MVA Triplex in people who are waiting for a liver transplant and have not been exposed to cytomegalovirus (CMV) before. CMV is a common virus that can cause problems after a transplant. The study aims to see if getting two doses of the CMV-MVA Triplex vaccine before your transplant can reduce the number of days you need antiviral medicine for CMV in the first 100 days after your transplant. Some participants will receive the vaccine, while others will receive a placebo (an inactive substance). Researchers will also monitor for any side effects from the vaccine.

Study design
This is a multi-center interventional study planning to enroll 416 participants. It compares the CMV-MVA Triplex vaccine to a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will track the total days of CMV antiviral therapy within the first 100 days after transplantation. They will also monitor for adverse reactions within 7 days of each vaccine dose and serious adverse events within 100 days after the first dose.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06075745

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Recruiting
PHASE2Ages 18+InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~416 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:CMV-MVA TriplexPlacebo for CMV-MVA Triplex

At a glance

Recruiting sites
17 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total days of Cytomegalovirus (CMV) active antiviral therapy (AVT) in CMV seropositive donor (D+) and seronegative (R-) and (D+R-) liver transplant recipients
Measured over Within the first 100 days post-transplantation
+5 more outcomes measured

Conditions

Liver Transplant

Explore related trials

CytomegalovirusLiver Transplantation

Where it's being run

18 sites across 15 states
California3
Pennsylvania2
Alabama1
Florida1
Georgia1
Illinois1
Maryland1
Michigan1

Study leadership

  • Ajit P Limaye, MD · STUDY_CHAIR · University of California, San Francisco: Transplantation
  • Cindy Fisher, M.D. · STUDY_CHAIR · University of Washington Medical Center: Transplantation

Who to contact

Saima Aslam, MD
[email protected]
619-543-6146
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • Total days of Cytomegalovirus (CMV) active antiviral therapy (AVT) in CMV seropositive donor (D+) and seronegative (R-) and (D+R-) liver transplant recipientsWithin the first 100 days post-transplantation
  • Percent of participants with solicited adverse reactionsWithin 7 days of each dose

    Consisting of local reactions including: injection site pain, swelling, erythema (redness); systemic reactions: fever, headache, muscle ache, fatigue)

  • Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)Within 100 days after initial dose
  • Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)Within 28 days after each dose
  • Percent of participants with pre-transplant treatment emergent adverse events (TEAE)Within 28 days after each dose

    Grade \>=3 severity or increase of severity of baseline abnormality that results in grade \>= 3 severity

  • Percent of participants with treatment emergent serious adverse events (TESAE)Throughout the study

    Grade \>= 4 severity