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CMV vaccine for liver transplant candidates

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)

Phase 2 Interventional National Institute of Allergy and Infectious Diseases (NIAID) · NCT06075745

This study is testing a new vaccine for people waiting for a liver transplant to see if it can help prevent a virus called CMV and reduce the need for antiviral treatment after the transplant.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment416 (estimated)
Ages18 Years and up
SexAll
SponsorNational Institute of Allergy and Infectious Diseases (NIAID) NIH
Drugs / interventionsAlemtuzumab, Rituximab, Chemotherapy, immunotherapy, methotrexate, cyclophosphamide, prednisone
Locations18 sites (Birmingham, Alabama and 17 other locations)
Trial IDNCT06075745 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex vaccine in CMV seronegative patients awaiting liver transplants. Participants will receive two doses of the vaccine prior to transplantation to assess its impact on the duration of CMV antiviral therapy in the first 100 days post-transplant. The study aims to improve outcomes for liver transplant recipients by preventing CMV disease through a preemptive therapy approach.

Who should consider this trial

Good fit: Ideal candidates are CMV seronegative individuals who are listed for a first liver transplant and are expected to undergo the procedure within the next 1-12 months.

Not a fit: Patients who are CMV seropositive or those who have a history of positive CMV serology will not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the need for antiviral therapy and improve recovery outcomes for liver transplant patients.

How similar studies have performed: While there have been studies on CMV vaccines, this specific approach in liver transplant candidates is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 17 other locations

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Liver TransplantCytomegalovirusVaccineOrthotopic Liver Transplant
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.