Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)
National Institute of Allergy and Infectious Diseases (NIAID)
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 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 with…
Interventions
- DrugCMV-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
- DrugPlacebo for CMV-MVA Triplex
Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex
Locations (18)
- University of Alabama at Birmingham, School of MedicineBirmingham, Alabama
- University of California, San Diego School of MedicineLa Jolla, California
- Stanford UniversityRedwood City, California
- University of California, San FranciscoSan Francisco, California
- University of Miami, Jackson Memorial HospitalMiami, Florida
- Emory University HospitalAtlanta, Georgia