[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521911":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":26,"locations":39,"responsibleParty":304,"collaborators":26,"id":306,"slug":307,"hasResults":308,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":308,"sex":314,"minAge":315,"maxAge":26,"enrollmentInfo":316,"targetDuration":26,"studyType":319,"phases":320,"briefSummary":322,"conditions":323,"keywords":325,"overallStatus":56,"whyStopped":26,"lastUpdateSubmitDate":329,"lastUpdatePostDateStruct":330,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":338},{"fullName":5,"class":6},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaccine Arm","EXPERIMENTAL","Participants in this arm will receive two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine",[13],"Drug: CMV-MVA Triplex",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Arm","PLACEBO_COMPARATOR","Participants will receive two doses of matching placebo of the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine",[19],"Drug: Placebo for CMV-MVA Triplex",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","CMV-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\u002FmL in a supplied volume of 1.0 mL",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo for CMV-MVA Triplex","Arm 2 participants receive two doses of matching placebo CMV-MVA Triplex",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Ajit P Limaye, MD","University of California, San Francisco: Transplantation","STUDY_CHAIR",{"name":37,"affiliation":38,"role":35},"Cindy Fisher, M.D.","University of Washington Medical Center: Transplantation",[40,54,71,85,99,114,128,143,158,173,188,203,218,233,247,261,275,290],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":26},"University of Alabama at Birmingham, School of Medicine","WITHDRAWN","Birmingham","Alabama","35233","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-86.80249,33.52066,{"lat":52,"lon":51},{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":46,"countryCode":47,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"University of California, San Diego School of Medicine","RECRUITING","La Jolla","California","92093",{"type":49,"coordinates":61},[62,63],-117.2742,32.84727,{"lat":63,"lon":62},[66],{"name":67,"role":68,"phone":69,"phoneExt":26,"email":70},"Saima Aslam, MD","CONTACT","619-543-6146","saslam@health.ucsd.edu",{"facility":72,"status":56,"city":73,"state":58,"zip":74,"country":46,"countryCode":47,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Stanford University","Redwood City","94063-3126",{"type":49,"coordinates":76},[77,78],-122.23635,37.48522,{"lat":78,"lon":77},[81],{"name":82,"role":68,"phone":83,"phoneExt":26,"email":84},"Dora Yuk-Wai Ho, MD, PhD","650-736-2442","jsbach@stanford.edu",{"facility":86,"status":56,"city":87,"state":58,"zip":88,"country":46,"countryCode":47,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"University of California, San Francisco","San Francisco","94143-0000",{"type":49,"coordinates":90},[91,92],-122.41942,37.77493,{"lat":92,"lon":91},[95],{"name":96,"role":68,"phone":97,"phoneExt":26,"email":98},"Monica Fung, MD, MPH","415-353-1275","monica.fung@ucsf.edu",{"facility":100,"status":56,"city":101,"state":102,"zip":103,"country":46,"countryCode":47,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"University of Miami, Jackson Memorial Hospital","Miami","Florida","33136-1003",{"type":49,"coordinates":105},[106,107],-80.19366,25.77427,{"lat":107,"lon":106},[110],{"name":111,"role":68,"phone":112,"phoneExt":26,"email":113},"Yoichiro Natori, MD, MPH","Please email","yxn138@med.miami.edu",{"facility":115,"status":56,"city":116,"state":117,"zip":118,"country":46,"countryCode":47,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"Emory University Hospital","Atlanta","Georgia","30322-0000",{"type":49,"coordinates":120},[121,122],-84.38798,33.749,{"lat":122,"lon":121},[125],{"name":126,"role":68,"phone":112,"phoneExt":26,"email":127},"Aneesh Mehta","aneesh.mehta@emory.edu",{"facility":129,"status":56,"city":130,"state":131,"zip":132,"country":46,"countryCode":47,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"Northwestern University, Feinberg School of Medicine","Chicago","Illinois","60611-0000",{"type":49,"coordinates":134},[135,136],-87.65005,41.85003,{"lat":136,"lon":135},[139],{"name":140,"role":68,"phone":141,"phoneExt":26,"email":142},"Michael Angarone, DO","312-695-6601","m-angarone@northwestern.edu",{"facility":144,"status":56,"city":145,"state":146,"zip":147,"country":46,"countryCode":47,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Johns Hopkins University School of Medicine","Baltimore","Maryland","21205-0000",{"type":49,"coordinates":149},[150,151],-76.61219,39.29038,{"lat":151,"lon":150},[154],{"name":155,"role":68,"phone":156,"phoneExt":26,"email":157},"Robin Avery, MD","410-614-6702","ravery4@jhmi.edu",{"facility":159,"status":56,"city":160,"state":161,"zip":162,"country":46,"countryCode":47,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"University of Michigan Medical Center","Ann Arbor","Michigan","48109-1274",{"type":49,"coordinates":164},[165,166],-83.74088,42.27756,{"lat":166,"lon":165},[169],{"name":170,"role":68,"phone":171,"phoneExt":26,"email":172},"Kevin Gregg, MD","734-232-1486","kvngregg@med.umich.edu",{"facility":174,"status":56,"city":175,"state":176,"zip":177,"country":46,"countryCode":47,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Mayo Clinic, Rochester - College of Medicine and Science","Rochester","Minnesota","55905-0001",{"type":49,"coordinates":179},[180,181],-92.4699,44.02163,{"lat":181,"lon":180},[184],{"name":185,"role":68,"phone":186,"phoneExt":26,"email":187},"Raymund Razonable, MD","507-255-7761","Razonable.Raymund@mayo.edu",{"facility":189,"status":56,"city":190,"state":191,"zip":192,"country":46,"countryCode":47,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"University of Nebraska Medical Center","Omaha","Nebraska","68198-7835",{"type":49,"coordinates":194},[195,196],-95.94043,41.25626,{"lat":196,"lon":195},[199],{"name":200,"role":68,"phone":201,"phoneExt":26,"email":202},"Sias Scherger, MD","402-559-8650","sscherger@unmc.edu",{"facility":204,"status":56,"city":205,"state":206,"zip":207,"country":46,"countryCode":47,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Duke University School of Medicine","Durham","North Carolina","27710-1000",{"type":49,"coordinates":209},[210,211],-78.89862,35.99403,{"lat":211,"lon":210},[214],{"name":215,"role":68,"phone":216,"phoneExt":26,"email":217},"Matthew Kappus, MD","919-385-5487","matthew.kappus@duke.edu",{"facility":219,"status":56,"city":220,"state":221,"zip":222,"country":46,"countryCode":47,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"Oregon Health & Sciences University","Portland","Oregon","97239-3098",{"type":49,"coordinates":224},[225,226],-122.67621,45.52345,{"lat":226,"lon":225},[229],{"name":230,"role":68,"phone":231,"phoneExt":26,"email":232},"Lynne Strasfeld, MD","503-494-7735","strasfel@ohsu.edu",{"facility":234,"status":56,"city":235,"state":236,"zip":237,"country":46,"countryCode":47,"cosmosGeoPoint":238,"geoPoint":242,"contacts":243},"University of Pennsylvania School of Medicine","Philadelphia","Pennsylvania","19104-5127",{"type":49,"coordinates":239},[240,241],-75.16362,39.95238,{"lat":241,"lon":240},[244],{"name":245,"role":68,"phone":112,"phoneExt":26,"email":246},"Emily Blumberg, MD","eblumber@pennmedicine.upenn.edu",{"facility":248,"status":56,"city":249,"state":236,"zip":250,"country":46,"countryCode":47,"cosmosGeoPoint":251,"geoPoint":255,"contacts":256},"University of Pittsburgh Medical Center","Pittsburgh","15213-0000",{"type":49,"coordinates":252},[253,254],-79.99589,40.44062,{"lat":254,"lon":253},[257],{"name":258,"role":68,"phone":259,"phoneExt":26,"email":260},"Fernanda Silveira, MD, MS","412-648-6512","silvfd@upmc.edu",{"facility":262,"status":56,"city":263,"state":264,"zip":265,"country":46,"countryCode":47,"cosmosGeoPoint":266,"geoPoint":270,"contacts":271},"Vanderbilt University School of Medicine","Nashville","Tennessee","37232-0011",{"type":49,"coordinates":267},[268,269],-86.78444,36.16589,{"lat":269,"lon":268},[272],{"name":273,"role":68,"phone":112,"phoneExt":26,"email":274},"Suzanne Sharpton, MD","suzanne.sharpton@vumc.org",{"facility":276,"status":56,"city":277,"state":278,"zip":279,"country":46,"countryCode":47,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"University of Texas Southwestern Medical Center","Dallas","Texas","75390-0000",{"type":49,"coordinates":281},[282,283],-96.80667,32.78306,{"lat":283,"lon":282},[286],{"name":287,"role":68,"phone":288,"phoneExt":26,"email":289},"Ricardo La Hoz, MD","205-306-5037","ricardo.lahoz@utsouthwestern.edu",{"facility":38,"status":56,"city":291,"state":292,"zip":293,"country":46,"countryCode":47,"cosmosGeoPoint":294,"geoPoint":298,"contacts":299},"Seattle","Washington","98195",{"type":49,"coordinates":295},[296,297],-122.33207,47.60621,{"lat":297,"lon":296},[300],{"name":301,"role":68,"phone":302,"phoneExt":26,"email":303},"Cindy P. Fisher, MD","206-598-9149","celaine@uw.edu",{"type":305,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100521911","phase-2-cytomegalovirus-cmv-vaccine-in-orthotopic-liver-transplant-candidates-100521911",false,"NCT06075745","Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates","Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)","COLT","Inclusion Criteria:\n\n1. Subject must be able to understand and provide informed consent\n2. 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)\n3. Negative human immunodeficiency virus (HIV) testing and no clinical suspicion of HIV infection\n4. Planned for a first living donor liver transplant or listed\u002Fanticipated to be listed for a first deceased donor liver transplant.\n5. Anticipated to receive a liver transplant within 1-12 months\n6. 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\u002FmL 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)\n7. 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\u002Fbirth 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\u002Fplacebo dose. For acceptable contraception methods that are more than 80 percent effective, see Food and Drug Administration (FDA) Office of Women's Health (http:\u002F\u002Fwww.fda.gov\u002Fbirthcontrol)\n8. The most recent platelet count is \\>= 20,000 cells\u002Fmm\\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased \\\u003C 20,000 cells\u002Fmm\\^3 at time of study IP administration.\n\nEligibility criteria required: Dose 2:\n\n1. Most recent platelet count \\>= 20,000 cells\u002Fmm\\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased \\\u003C 20,000 cells\u002Fmm\\^3 since last result\n2. For women of reproductive potential as defined previously, a negative serum or urine pregnancy test (performed within 72 hours)\n\nExclusion Criteria:\n\n1. Women who are breastfeeding or planning to breastfeed\n2. Prior Cytomegalovirus (CMV) vaccination\n3. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes coronavirus disease (COVID) convalescent plasma)\n4. Currently enrolled in another interventional study that, in the investigator's opinion, could affect the evaluation of safety and\u002For vaccine effect outcomes\n5. Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.)\n6. Receipt of immunosuppression:\n\n   * Within the last 3 months prior to randomization:\n\n     * 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)\n     * Systemic immunosuppressive agents (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, mTOR inhibitors, TNF-alpha inhibitors) and\u002For combination immunosuppressive drugs for any autoimmune or other conditions in the last 3 months except corticosteroids as below\n   * Within the last 28 days prior to randomization: averaged daily corticosteroid therapy dose ≥20 mg of prednisone equivalent\n   * Within the last 6 months prior to randomization: receipt of T- or Bcell depleting agents (e.g. ATG, Alemtuzumab, Rituximab)\n7. Transplant status 1A or in the opinion of the investigator is likely to receive a transplant within the next month\n8. At the time of randomization, either listed for, or, in the opinion of the investigator, likely to receive any non-liver organ transplant\n9. Receipt of a clinical vaccine \\\u003C 14 days before or planned to receive a clinical vaccine \\\u003C14 days after the study agent\n10. Known allergy to any component of the study agent\n11. 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\n\nExclusion criteria required: Dose 2:\n\n1. Anaphylaxis or other severe reaction (Grade 4) considered definitely or probably attributable to dose 1\n2. Receipt of liver transplant prior to dose 2\n3. The participant must not have any severe acute illness or other factor, that, in the opinion of the investigator, requires postponement of dose 2 because of safety concerns. The participant can be re-evaluated for eligibility throughout the window of eligibility for the dose 2, once the illness or other factor has improved or resolved\n4. Receipt of a clinical vaccine \\\u003C 14 days before or planned to receive a clinical vaccine \\\u003C14 days after the study agent","ALL","18 Years",{"count":317,"type":318},416,"ESTIMATED","INTERVENTIONAL",[321],"PHASE2","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.",[324],"Liver Transplant",[326,327,328],"Cytomegalovirus","Vaccine","Orthotopic Liver Transplant","2026-06-30",{"date":331,"type":332},"2026-07-02","ACTUAL",{"date":334,"type":332},"2024-03-05",{"date":336,"type":318},"2028-02-28",{"name":5,"class":6},18]