Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

• 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)

• 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.

⁃ Eligibility criteria required: Dose 2:

• Most recent platelet count \>= 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 since last result

• For women of reproductive potential as defined previously, a negative serum or urine pregnancy test (performed within 72 hours)

Locations
United States
Alabama
University of Alabama at Birmingham, School of Medicine
WITHDRAWN
Birmingham
California
University of California, San Diego School of Medicine
RECRUITING
La Jolla
Stanford University
RECRUITING
Redwood City
University of California, San Francisco
RECRUITING
San Francisco
Florida
University of Miami, Jackson Memorial Hospital
RECRUITING
Miami
Georgia
Emory University Hospital
RECRUITING
Atlanta
Illinois
Northwestern University, Feinberg School of Medicine
RECRUITING
Chicago
Maryland
Johns Hopkins University School of Medicine
RECRUITING
Baltimore
Michigan
University of Michigan Medical Center
RECRUITING
Ann Arbor
Minnesota
Mayo Clinic, Rochester - College of Medicine and Science
RECRUITING
Rochester
North Carolina
Duke University School of Medicine
RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Oregon
Oregon Health & Sciences University
RECRUITING
Portland
Pennsylvania
University of Pennsylvania School of Medicine
RECRUITING
Philadelphia
University of Pittsburgh Medical Center
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University School of Medicine
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Washington
University of Washington Medical Center: Transplantation
RECRUITING
Seattle
Time Frame
Start Date: 2024-03-05
Estimated Completion Date: 2028-02-28
Participants
Target number of participants: 416
Treatments
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
Sponsors
Leads: National Institute of Allergy and Infectious Diseases (NIAID)

This content was sourced from clinicaltrials.gov