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Liver TransplantPhase 2COLTNCT06075745

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

A Phase 2 study testing CMV-MVA Triplex in people with Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Transplant
What is being tested?
CMV-MVA Triplex
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
18 sitesUnited States
Study dates
5 Mar 2024to 28 Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)

Who cannot join

  • 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:
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  • 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
  • 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

Trial locations and contacts

18 sites in 1 country. Contact the study team or a site near you to ask about taking part.

18 sites in 1 country

United States18 sites, 16 recruiting

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109-1274

    Zoe Raglow, MD, 734-647-5899, zoraglow@med.umich.edu

    Recruiting

  • Emory University Hospital

    Atlanta, Georgia, 30322-0000

    Active, not recruiting

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205-0000

    Robin Avery, MD, 410-614-6702, ravery4@jhmi.edu

    Recruiting

  • University of Alabama at Birmingham, School of Medicine

    Birmingham, Alabama, 35233

    Withdrawn

  • Northwestern University, Feinberg School of Medicine

    Chicago, Illinois, 60611-0000

    Michael Angarone, DO, 312-695-6601, m-angarone@northwestern.edu

    Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390-0000

    Ricardo La Hoz, MD, 205-306-5037, ricardo.lahoz@utsouthwestern.edu

    Recruiting

  • Duke University School of Medicine

    Durham, North Carolina, 27710-1000

    Matthew Kappus, MD, 919-385-5487, matthew.kappus@duke.edu

    Recruiting

  • University of California, San Diego School of Medicine

    La Jolla, California, 92093

    Saima Aslam, MD, 619-543-6146, saslam@health.ucsd.edu

    Recruiting

  • University of Miami, Jackson Memorial Hospital

    Miami, Florida, 33136-1003

    Yoichiro Natori, MD, MPH, Please email, yxn138@med.miami.edu

    Recruiting

  • Vanderbilt University School of Medicine

    Nashville, Tennessee, 37232-0011

    Suzanne Sharpton, MD, Please email, suzanne.sharpton@vumc.org

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7835

    Sias Scherger, MD, 402-559-8650, sscherger@unmc.edu

    Recruiting

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104-5127

    Emily Blumberg, MD, Please email, eblumber@pennmedicine.upenn.edu

    Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213-0000

    Fernanda Silveira, MD, MS, 412-648-6512, silvfd@upmc.edu

    Recruiting

  • Oregon Health & Sciences University

    Portland, Oregon, 97239-3098

    Lynne Strasfeld, MD, 503-494-7735, strasfel@ohsu.edu

    Recruiting

  • Stanford University

    Redwood City, California, 94063-3126

    Dora Yuk-Wai Ho, MD, PhD, 650-736-2442, jsbach@stanford.edu

    Recruiting

  • Mayo Clinic, Rochester - College of Medicine and Science

    Rochester, Minnesota, 55905-0001

    Raymund Razonable, MD, 507-255-7761, Razonable.Raymund@mayo.edu

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143-0000

    Monica Fung, MD, MPH, 415-353-1275, monica.fung@ucsf.edu

    Recruiting

  • University of Washington Medical Center: Transplantation

    Seattle, Washington, 98195

    Cindy P. Fisher, MD, 206-598-9149, celaine@uw.edu

    Recruiting

Other trials in United States

About this study

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

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.

Being tested
CMV-MVA Triplex, Placebo for CMV-MVA Triplex
Keywords
Cytomegalovirus, Vaccine, Orthotopic Liver Transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CMV-MVA TriplexDrug

    The dosage used will be 5.0 x 10^8 pfu, administered under sterile conditions intramuscularly. The CMV-MVA Triplex vaccine lots range in titre from 5.0 to 9.0 x 10^8 pfu/mL in a supplied volume of 1.0 mL

  • Placebo for CMV-MVA TriplexDrug

    Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex

Study groups in NCT06075745
Study groupRoleWhat they receive
Vaccine ArmExperimentalParticipants in this arm will receive two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine
Receives: Drug: CMV-MVA Triplex
Placebo ArmPlacebo comparatorParticipants will receive two doses of matching placebo of the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine
Receives: Drug: Placebo for CMV-MVA Triplex

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total days of Cytomegalovirus (CMV) active antiviral therapy (AVT) in CMV seropositive donor (D+) and seronegative (R-) and (D+R-) liver transplant recipients

    Measured: Within the first 100 days post-transplantation

  2. Percent of participants with solicited adverse reactions

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

    Measured: Within 7 days of each dose

  3. Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)

    Measured: Within 100 days after initial dose

  4. Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)

    Measured: Within 28 days after each dose

  5. Percent of participants with pre-transplant treatment emergent adverse events (TEAE)

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

    Measured: Within 28 days after each dose

  6. Percent of participants with treatment emergent serious adverse events (TESAE)

    Grade >= 4 severity

    Measured: Throughout the study

Secondary outcomes (7)

  1. Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop Endpoint-Committee adjudicated Cytomegalovirus (CMV) disease

    Measured: By 6 months post-transplant (Tx)

  2. Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop investigator-reported Cytomegalovirus (CMV) disease

    Measured: By 6 months post-transplant (Tx)

  3. Time to onset of Endpoint-Committee adjudicated Cytomegalovirus (CMV) disease in seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients

    Measured: By 6 months post-transplant (Tx)

  4. Time to onset of Endpoint-Committee adjudicated Cytomegalovirus (CMV) in seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients

    Measured: By 6 months post-transplant (Tx)

  5. Time to onset of investigator-reported Cytomegalovirus (CMV) disease

    Measured: By 6 months post-transplant (Tx)

  6. Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop CMV DNAemia >= 1000 IU/mL

    Measured: Within first 100 days post-transplant (Tx)

  7. Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop Endpoint committee adjudicated CMV disease

    Measured: Within first 100 days post-transplant (Tx)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2023
  2. Study start5 Mar 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion28 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
416 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06075745
Sponsor's protocol ID
DAIT CTOT-44
Acronym
COLT
Status last verified
Sep 2026
First submitted
4 Oct 2023
Last updated
16 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The plan is to share data upon completion of the study in: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CMV-MVA Triplex in people with Liver Transplant, run by National Institute of Allergy and Infectious Diseases (NIAID) at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total days of Cytomegalovirus (CMV) active antiviral therapy (AVT) in CMV seropositive donor (D+) and seronegative (R-) and (D+R-) liver transplant recipients (time frame: Within the first 100 days post-transplantation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06075745.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.

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