NCT06075745 · National Institute of Allergy and Infectious Diseases (NIAID)
Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
(COLT)
What this study is about
This is a multi-center clinical trial in Cytomegalovirus (CMV) seronegative forward-looking liver transplant recipients to determine the effectiveness of two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant.
View original scientific description
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.
Interventions
DRUG
CMV-MVA Triplex
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
DRUG
Placebo for CMV-MVA Triplex
Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex
Primary outcome measures
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
Percent of participants with solicited adverse reactions
Time frame: Within 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)
Time frame: Within 100 days after initial dose
Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)
Time frame: Within 28 days after each dose
Percent of participants with pre-transplant treatment emergent adverse events (TEAE)
Time frame: 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)
Time frame: Throughout the study
Grade \>= 4 severity
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 n
Where
- Birmingham, Alabama
- La Jolla, California
- Redwood City, California
- San Francisco, California
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Baltimore, Maryland
- Ann Arbor, Michigan
- Rochester, Minnesota
- Omaha, Nebraska
- Durham, North Carolina
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 24, 2026 · Source of record for eligibility and locations