Actively Recruiting
Cytomegalovirus Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-02
416
Participants Needed
18
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of two doses of the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex vaccine in adults who are CMV seronegative and are about to receive a liver transplant. This Phase 2 clinical trial focuses on liver transplant recipients who receive an organ from a CMV seropositive donor and aims to see if the vaccine can reduce the duration of CMV antiviral therapy needed in the first 100 days after transplant. The study includes a preemptive therapy protocol to prevent CMV disease in these patients. Participants will be randomly assigned to receive either two doses of the CMV-MVA Triplex vaccine or two doses of a matching placebo before their transplant. The vaccine is given as an intramuscular injection using a dose ranging from 5.0 to 9.0 x 10^8 pfu/mL in a volume of 1.0 mL. The study monitors safety closely through adverse event reporting at various time points after each dose and throughout the study. During the trial, participants will be closely followed with assessments including monitoring for CMV antiviral therapy usage, reactions to the vaccine, and occurrences of CMV disease up to six months post-transplant. Laboratory tests, including CMV DNAemia measurements, and clinical evaluations will be performed to assess vaccine impact and safety. The total time participants are observed includes at least 100 days post-transplant with safety follow-up extending throughout the study period.
CONDITIONS
Brief Title
Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and provide informed consent
- Negative for CMV IgG antibody within 12 months and no prior positive CMV serology
- Negative HIV test and no suspicion of HIV infection
- Planned for first living or deceased donor liver transplant
- Expected to receive liver transplant within 1 to 12 months
- Negative pregnancy test within 72 hours before enrollment for individuals of reproductive potential
- Willing to practice contraception or avoid conception for at least one month after last vaccine/placebo dose if of reproductive potential
- Platelet count ≥ 20,000 cells/mm³ within 3 months prior to enrollment and stable
- For dose 2, platelet count ≥ 20,000 cells/mm³ and negative pregnancy test for women of reproductive potential within 72 hours before dose
You will not qualify if you...
- Women who are breastfeeding or planning to breastfeed
- Prior CMV vaccination
- Received immunoglobulin or CMV-specific immunoglobulin in past 3 months
- Enrolled in another interventional study that could affect safety or vaccine outcomes
- Prior receipt of any stem cell transplant
- Immunosuppression within last 3 months including systemic chemotherapy or immunosuppressive agents, except certain corticosteroids
- High-dose corticosteroid use within last 28 days prior to randomization
- Receipt of T- or B-cell depleting agents within last 6 months
- Transplant status 1A or likely to receive transplant within next month
- Listed for or likely to receive non-liver organ transplant
- Received or planned to receive any clinical vaccine within 14 days before or after study agent
- Known allergy to any component of the study agent
- Any medical condition or findings that may pose additional risk or affect study participation or data quality
- For dose 2, severe reaction to dose 1, prior liver transplant, severe acute illness requiring postponement, or recent vaccination as above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until liver transplant
Participants receive two doses of either the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex vaccine or matching placebo.
2 dosing visits plus follow-up visits within 28 days after each dose
Duration - Up to 6 months post-transplant
Participants are monitored for safety and effectiveness outcomes up to 6 months post-transplant.
Visits occur within 7 days after each dose and up to 6 months post-transplant
Trial Site Locations
Total: 18 locations
1
University of Alabama at Birmingham, School of Medicine
Birmingham, Alabama, United States, 35233
Withdrawn
2
University of California, San Diego School of Medicine
La Jolla, California, United States, 92093
Actively Recruiting
3
Stanford University
Redwood City, California, United States, 94063-3126
Actively Recruiting
4
University of California, San Francisco
San Francisco, California, United States, 94143-0000
Actively Recruiting
5
University of Miami, Jackson Memorial Hospital
Miami, Florida, United States, 33136-1003
Actively Recruiting
6
Emory University Hospital
Atlanta, Georgia, United States, 30322-0000
Actively Recruiting
7
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611-0000
Actively Recruiting
8
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205-0000
Actively Recruiting
9
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109-1274
Actively Recruiting
10
Mayo Clinic, Rochester - College of Medicine and Science
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
11
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198-7835
Actively Recruiting
12
Duke University School of Medicine
Durham, North Carolina, United States, 27710-1000
Actively Recruiting
13
Oregon Health & Sciences University
Portland, Oregon, United States, 97239-3098
Active, Not Recruiting
14
University of Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-5127
Actively Recruiting
15
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213-0000
Actively Recruiting
16
Vanderbilt University School of Medicine
Nashville, Tennessee, United States, 37232-0011
Actively Recruiting
17
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390-0000
Actively Recruiting
18
University of Washington Medical Center: Transplantation
Seattle, Washington, United States, 98195
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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