RecruitingLiver Transplant

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Eligible age

18+ yrs

Accepts

All genders

Locations

15 states

Healthy volunteers

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About this study

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.

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

You may qualify if…

✓ 1. 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 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)
✓ 7. 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 (hormonal or barrier method) or agree to not participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for at least 1 month following the last vaccine/placebo dose. For acceptable contraception methods that are more than 80 percent effective, see Food and Drug Administration (FDA) Office of Women's Health (http://www.fda.gov/birthcontrol)
✓ 8. 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.

You may not qualify if…

✕ 1. Women who are breastfeeding or planning to breastfeed
✕ 2. Prior Cytomegalovirus (CMV) vaccination
✕ 3. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes coronavirus disease (COVID) convalescent plasma)
✕ 4. Currently enrolled in another interventional study that, in the investigator's opinion, could affect the evaluation of safety and/or vaccine effect outcomes
✕ 5. Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.)
✕ 6. 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 excluded)