Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06075745
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Liver Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CMV-MVA Triplex — DRUG
    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
  • Placebo for CMV-MVA Triplex — DRUG
    Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex

Study Details

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.

Key Dates

Start date
Mar 5, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Feb 28, 2028

Study Design

Enrollment
416 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vaccine Arm
    Participants in this arm will receive two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine
  • Placebo Comparator: Placebo Arm
    Participants will receive two doses of matching placebo of the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine

Primary Outcome Measure

Total days of Cytomegalovirus (CMV) active antiviral therapy (AVT) in CMV seropositive donor (D+) and seronegative (R-) and (D+R-) liver transplant recipients [ Time Frame: Within the first 100 days post-transplantation ]

Locations (18)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham, School of MedicineBirminghamAlabama35233-
University of California, San Diego School of MedicineLa JollaCalifornia92093
Saima Aslam, MD
[email protected]
619-543-6146
Stanford UniversityRedwood CityCalifornia94063-3126
Dora Yuk-Wai Ho, MD, PhD
[email protected]
650-736-2442
University of California, San FranciscoSan FranciscoCalifornia94143-0000
Monica Fung, MD, MPH
[email protected]
415-353-1275
University of Miami, Jackson Memorial HospitalMiamiFlorida33136-1003
Yoichiro Natori, MD, MPH
[email protected]
Please email
Emory University HospitalAtlantaGeorgia30322-0000
Aneesh Mehta
[email protected]
Please email
Northwestern University, Feinberg School of MedicineChicagoIllinois60611-0000
Michael Angarone, DO
[email protected]
312-695-6601
Johns Hopkins University School of MedicineBaltimoreMaryland21205-0000
Robin Avery, MD
[email protected]
410-614-6702
University of Michigan Medical CenterAnn ArborMichigan48109-1274
Kevin Gregg, MD
[email protected]
734-232-1486
Mayo Clinic, Rochester - College of Medicine and ScienceRochesterMinnesota55905-0001
Raymund Razonable, MD
[email protected]
507-255-7761
University of Nebraska Medical CenterOmahaNebraska68198-7835
Sias Scherger, MD
[email protected]
402-559-8650
Duke University School of MedicineDurhamNorth Carolina27710-1000
Matthew Kappus, MD
[email protected]
919-385-5487
Oregon Health & Sciences UniversityPortlandOregon97239-3098-
University of Pennsylvania School of MedicinePhiladelphiaPennsylvania19104-5127
Emily Blumberg, MD
[email protected]
Please email
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-0000
Fernanda Silveira, MD, MS
[email protected]
412-648-6512
Vanderbilt University School of MedicineNashvilleTennessee37232-0011
Suzanne Sharpton, MD
[email protected]
Please email
University of Texas Southwestern Medical CenterDallasTexas75390-0000
Ricardo La Hoz, MD
[email protected]
205-306-5037
University of Washington Medical Center: TransplantationSeattleWashington98195
Cindy P. Fisher, MD
[email protected]
206-598-9149

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham, School of Medicine· Birmingham, ALUniversity of California, San Diego School of Medicine· La Jolla, CAStanford University· Redwood City, CAUniversity of California, San Francisco· San Francisco, CAUniversity of Miami, Jackson Memorial Hospital· Miami, FLEmory University Hospital· Atlanta, GA

Related Studies