Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
Study NCT ID:
NCT05683457
Status:
RECRUITING
Last Update Posted:
2025-03-13
First Post:
2023-01-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D006561', 'term': 'Herpes Simplex'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722750', 'term': 'mRNA-1647 cytomegalovirus vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 224}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-12', 'studyFirstSubmitDate': '2023-01-04', 'studyFirstSubmitQcDate': '2023-01-04', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy', 'timeFrame': 'Day 100 to Month 9'}, {'measure': 'Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)', 'timeFrame': 'Up to Day 187 (7 days after last study injection)'}, {'measure': 'Number of Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to Day 205 (25 days after last study injection)'}, {'measure': 'Number of Participants with Severe AEs', 'timeFrame': 'Up to Day 365'}, {'measure': 'Number of Participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 365'}, {'measure': 'Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)', 'timeFrame': 'Up to Day 365'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with First Occurrence of All CS-CMVi Events as Measured by Initiation of Anti-CMV Antiviral and/or End-Organ Disease', 'timeFrame': 'Day 100 to Month 9'}, {'measure': 'Number of Participants with an Occurrence of CMV Viremia', 'timeFrame': 'Day 100 to Month 9', 'description': 'CMV Viremia is defined as ≥300 international units/milliliters (IU/mL).'}, {'measure': 'Number of Participants with CMV End-Organ Disease', 'timeFrame': 'Day 100 to Month 9'}, {'measure': 'Duration of CMV Viremia', 'timeFrame': 'Day 100 to Month 9'}, {'measure': 'Duration of CMV Treatment', 'timeFrame': 'Day 100 to Month 9'}, {'measure': 'Number of Participants with Non-Relapse Mortality at 9 Months Post-HCT.', 'timeFrame': 'Month 9'}, {'measure': 'Titer of CMV-Specific Neutralizing Antibody (nAb)', 'timeFrame': 'Days 42, 67, 92, 117, 180, 205 and 270'}, {'measure': 'Geometric Mean Titer (GMT) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)', 'timeFrame': 'Days 42, 67, 92, 117, 180, 205 and 270'}, {'measure': 'Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)', 'timeFrame': 'Days 42, 67, 92, 117, 180, 205 and 270'}, {'measure': 'Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline GMTs or GMCs', 'timeFrame': 'Days 42, 67, 92, 117, 180, 205 and 270'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human cytomegalovirus', 'Human Herpesvirus', 'mRNA-1647', 'Moderna', 'CMV', 'Cytomegalovirus Vaccine', 'Cytomegalovirus Infections', 'Cytomegalovirus Congenital', 'Virus Disease', 'Infection Viral', 'DNA Virus Infections', 'Messenger RNA', 'Hematopoietic cell transplantation'], 'conditions': ['Cytomegalovirus Infection']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 post-HCT through Month 9 post-HCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receipt of an allogeneic HCT.\n* CMV-seropositive, defined as a documented positive test for anti-CMV IgG.\n* High-risk for CMV: HCT from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis; or HCT from related or unrelated donor with at least one mismatch at any of the following human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCT from related or unrelated donor with myeloablative conditioning.\n* Persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first study injection.\n* Persons of childbearing potential who have practiced adequate contraception or have abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose.\n* Persons of childbearing potential who have agreed to continue adequate contraception or abstain from all activities that could result in pregnancy through 3 months after last study injection.\n* Persons who are not currently breast/chestfeeding.\n* Willingness to comply with study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* History of a diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.\n* A documented positive human immunodeficiency virus (HIV) test.\n* Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or any equivalent in-vivo T cell depleting agent within 12 months.\n* HCT with ex-vivo T cell depletion.\n* Low risk for CMV: HCT from related or unrelated donor with reduced intensity conditioning (RIC) and no other high-risk features.\n* History of prior hematopoietic cell transplantation within 12 months.\n* Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic study that may interfere with study outcome measures as determined by the Investigator.\n* Suspected or known allergic reaction to any component of any mRNA vaccine or its excipients.'}, 'identificationModule': {'nctId': 'NCT05683457', 'briefTitle': 'A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 2, Observer-Blind, Placebo-Controlled Proof-of-Concept Trial to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Patients Who Have Undergone Allogeneic Hematopoietic Cell Transplantation (HCT)', 'orgStudyIdInfo': {'id': 'mRNA-1647-P205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA-1647', 'description': 'Participants will receive mRNA-1647 by intramuscular (IM) injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.', 'interventionNames': ['Biological: mRNA-1647']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive mRNA-1647 matching placebo by IM injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'mRNA-1647', 'type': 'BIOLOGICAL', 'description': 'Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline).', 'armGroupLabels': ['mRNA-1647']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Moderna WeCare Team', 'role': 'CONTACT', 'email': 'WeCareClinicalTrials@modernatx.com', 'phone': '1-866-663-3762'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}