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New treatment option for Liver Transplant
Official title Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates
ClinicalTrials.gov ID: NCT06075745
What this study is testing
What is CMV-MVA Triplex?
CMV-MVA Triplex is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for liver transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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
You likely can't join if
- 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 treatment study that, in the investigator's opinion, could affect the evaluation of safety and/or vaccine effect...
- Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.)
- Receipt of immunosuppression:
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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)
- 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 treatment 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:
- 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...
- Systemic immunosuppressive agents (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, mTOR inhibitors, TNF-alpha inhibitors) and/or combination immunosuppressive drugs for any...
- 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...
- 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...
- Receipt of a clinical vaccine \< 14 days before or planned to receive a clinical vaccine \<14 days after the study agent
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- La Jolla, California, United States
- Redwood City, California, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Rochester, Minnesota, United States
- Omaha, Nebraska, United States
- Durham, North Carolina, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; La Jolla, California, United States; Redwood City, California, United States; San Francisco, California, United States; Miami, Florida, United States; Atlanta, Georgia, United States and 12 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.