Clinical Trials

Inclusion Criteria:

• Subject must be able to understand and provide informed consent.
• Age ≥ 18 years old at the time of informed consent.
• Negative for antibody to CMV as assessed in a CLIA-certified laboratory within 6 months of enrollment, and no history of prior positive CMV serology (IgG antibody).
• Negative screening test for HIV and no clinical suspicion of HIV infection.
• Listed for a first living or 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).
• 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% effective, see FDA Office of Women’s Health (http://www.fda.gov/birthcontrol).
• In the absence of contraindications, must have received adult vaccinations or have documented immunity as outlined in the NIAID DAIT Guidance for Patients in Transplant Trials (See Appendix 6).
• The most recent platelet count is ≥ 20,000 per mm3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased to < 20,000 per mm3 at the time of study IP administration.

Exclusion Criteria:

• Women who are breastfeeding or planning to breastfeed.
• Prior CMV vaccination.
• Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes COVID convalescent plasma).
• Currently enrolled in another interventional 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 (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 excluded);
    • Systemic immunosuppressive agents (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, mTOR inhibitors, TNF- inhibitors) and/or combination immunosuppressive drugs for any autoimmune or other conditions in the last 3 months, except corticosteroids as below.
  • 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 B-cell 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 or planned administration of:
  • Live, attenuated vaccine within 14 days of study agent;
  • Subunit or inactivated vaccine within 14 days of 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 study, may interfere with the participant’s ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/1/23. Questions regarding updates should be directed to the study team contact.