RecruitingPhase 2

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

United States416 participantsStarted 2024-03-05

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Within the first 100 days post-transplantation

Percent of participants with solicited adverse reactions

Timeframe: Within 7 days of each dose

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

Timeframe: Within 100 days after initial dose

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

Timeframe: Within 28 days after each dose

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

Timeframe: Within 28 days after each dose

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

Timeframe: Throughout the study

Trial details

NCT IDNCT06075745

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2027-06-30

View on ClinicalTrials.gov More Liver Transplant trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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)

What they're measuring

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

Timeframe: Within the first 100 days post-transplantation

Percent of participants with solicited adverse reactions

Timeframe: Within 7 days of each dose

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

Timeframe: Within 100 days after initial dose

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

Timeframe: Within 28 days after each dose

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

Timeframe: Within 28 days after each dose

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

Timeframe: Throughout the study

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria