Actively Recruiting
Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-04-02
416
Participants Needed
18
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 Cytomegalovirus (CMV) IgG antibody within 12 months and no prior positive CMV serology
- Negative for human immunodeficiency virus (HIV) and no clinical suspicion of HIV infection
- Planned for a first living donor or deceased donor liver transplant
- Expected to receive a liver transplant within 1 to 12 months
- For individuals of reproductive potential, negative pregnancy test within 72 hours prior to enrollment
- Agreement to use contraception or avoid conception for at least 1 month after last vaccine or placebo dose if sexually active and of reproductive potential
- Platelet count of at least 20,000 cells/mm^3 within 3 months prior to enrollment and not decreased below 20,000 at time of study drug administration
- For dose 2, platelet count remains at or above 20,000 cells/mm^3 and negative pregnancy test for women of reproductive potential within 72 hours prior to dose
You will not qualify if you...
- Women who are breastfeeding or planning to breastfeed
- Prior Cytomegalovirus (CMV) vaccination
- Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months
- Currently enrolled in another interventional study that may affect safety or vaccine evaluation
- Previous stem cell transplant of any type
- Receipt of systemic chemotherapy or immunotherapy for cancer within 3 months prior to randomization, except localized therapies for hepatocellular carcinoma
- Use of systemic immunosuppressive agents or combination drugs for autoimmune or other conditions within 3 months prior to randomization, except corticosteroids as specified
- Average daily corticosteroid dose of 20 mg or more prednisone equivalent within 28 days prior to randomization
- Receipt of T- or B-cell depleting agents within 6 months prior to randomization
- Transplant status 1A or expected to receive transplant within the next month
- Listed for or expected to receive any non-liver organ transplant at randomization
- Receipt or planned receipt of any clinical vaccine within 14 days before or after study agent
- Known allergy to any component of the study agent
- Any medical problems or findings that increase risks, interfere with study compliance, or affect data quality as judged by investigator
- For dose 2, severe reaction to dose 1, receipt of liver transplant prior to dose 2, severe acute illness delaying dose 2, or receipt/planned receipt of clinical vaccine within 14 days before or after study agent
AI-Screening
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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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