Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT04975893
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-21
First Post:
2021-07-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003586', 'term': 'Cytomegalovirus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722750', 'term': 'mRNA-1647 cytomegalovirus vaccine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 291}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2021-07-09', 'studyFirstSubmitQcDate': '2021-07-22', 'lastUpdatePostDateStruct': {'date': '2025-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)', 'timeFrame': 'Up to 3 years'}, {'measure': 'BP: GMTs of Antigen-Specific nAb and bAb', 'timeFrame': 'BP Month 0, BP Month 1, BP Month 3, BP Month 6, and BP Month 12'}, {'measure': 'BP: Number of Participants with Solicited Adverse Reactions (ARs)', 'timeFrame': 'Up to BP Day 7 (7 days after BP vaccination)'}, {'measure': 'BP: Number of Participants with Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to BP Day 28 (28 days after BP vaccination)'}, {'measure': 'BP: Number of Participants with Medically-Attended AEs (MAAEs)', 'timeFrame': 'Up to BP Month 6 (6 months after BP vaccination)'}, {'measure': 'BP: Number of Participants with Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study', 'timeFrame': 'Up to BP Month 12'}], 'secondaryOutcomes': [{'measure': 'Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation', 'timeFrame': 'Up to 3 years'}, {'measure': 'Primary Extension Phase: Number of Participants With SAEs', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Moderna', 'mRNA-1647', 'Cytomegalovirus', 'CMV', 'Cytomegalovirus Vaccine', 'Cytomegalovirus Infections', 'Cytomegalovirus Congenital', 'Virus Diseases', 'Infection Viral', 'DNA Virus Infections', 'Messenger RNA'], 'conditions': ['Cytomegalovirus Infection']}, 'descriptionModule': {'briefSummary': 'The main purpose of the extension phase of this study is to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative and CMV-seropositive adults who completed Study mRNA-1647-P202 (NCT04232280). For participants in the optional booster phase (BP), the main purpose is to evaluate the long-term immunogenicity and safety of the mRNA-1647 vaccine in both participants receiving a booster dose (BD) and those not receiving a BD, and to additionally evaluate the reactogenicity in participants receiving a BD.', 'detailedDescription': 'The study aims to explore the long-term potential differences in immunogenicity and key safety parameters following mRNA-1647 administration, participants who completed study mRNA-1647-P202, who are CMV-seronegative and who did not seroconvert due to primary CMV infection during the study will be enrolled. Study mRNA-1647-P202 participants who were CMV-seropositive at baseline, randomized to receive mRNA-1647 injection, and completed their final study visit will also be enrolled.\n\nNo study treatment will be administered during the primary extension phase of this study. Eligible participants enrolling in the primary extension phase who completed Study mRNA-1647-P202 may have received mRNA-1647 (either low dose, medium dose, or high dose) or placebo in CMV-seronegative participants and mRNA-1647 (either low dose, medium dose, or high dose) in CMV-seropositive participants.\n\nIn the optional BP, consenting and eligible participants will receive a single BD of the mRNA-1647 vaccine (medium dose). In the Observational Group of the optional BP, consenting and eligible participants will not receive study treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary Extension Phase:\n\n* Male and female participants who were CMV-seronegative at the Study mRNA-1647-P202 Screening visit, completed the final Study mRNA-1647-P202 visit, and remained CMV-seronegative at Screening for Study mRNA-1647-P202-EXT.\n* Male and female participants who were CMV-seropositive at the Study mRNA-1647-P202 Screening visit, were randomized to receive mRNA-1647 injection (and not placebo), and completed the final visit in Study mRNA-1647-P202.\n* Understands and agrees to comply with the trial procedures and provides written informed consent.\n* According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures.\n\nOptional Booster Phase:\n\nFor BD Recipients:\n\n\\- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 medium dose injection (and not placebo or other dose levels) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to receive a BD in the optional BP.\n\nFor Observational Group:\n\n\\- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 low dose or high dose injection (and not placebo or mRNA-1647 medium dose injection) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to enroll in the observational group.\n\nExclusion Criteria:\n\nPrimary Extension Phase:\n\n* Receipt of any CMV vaccine other than mRNA-1647.\n* 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 trial procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.\n\nOptional Booster Phase:\n\nFor BD Recipients:\n\n\\- Participants from the placebo, mRNA-1647 low dose, or mRNA-1647 medium dose groups in Study mRNA-1647-P202.\n\nFor Observational Group:\n\n\\- Participants from the placebo or mRNA-1647 medium dose groups in study mRNA-1647-P202.\n\nNote: Other protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04975893', 'briefTitle': 'A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 2, Non-Randomized, Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus mRNA-1647 Vaccine Including a Booster Dose in a Subset of Participants Who Completed Study mRNA-1647-P202', 'orgStudyIdInfo': {'id': 'mRNA-1647-P202-EXT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Primary Extension Phase', 'description': 'CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202.', 'interventionNames': ['Biological: mRNA-1647']}, {'type': 'EXPERIMENTAL', 'label': 'Optional Booster Phase - BD Recipients', 'description': 'Participants who opted to enroll into the optional Booster Phase will receive a single mRNA-1647 vaccine dose.', 'interventionNames': ['Other: mRNA-1647']}, {'type': 'OTHER', 'label': 'Optional Booster Phase - Observational Group', 'description': 'Participants who opted to enroll into the Observational Group will be followed in the optional BP until BP Month 12.', 'interventionNames': ['Biological: mRNA-1647']}], 'interventions': [{'name': 'mRNA-1647', 'type': 'BIOLOGICAL', 'description': 'No investigational product will be administered during the Primary Extension Phase or to the participants in the Observational Group.', 'armGroupLabels': ['Optional Booster Phase - Observational Group', 'Primary Extension Phase']}, {'name': 'mRNA-1647', 'type': 'OTHER', 'description': 'Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration', 'armGroupLabels': ['Optional Booster Phase - BD Recipients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61610', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Optimal Research, LLC', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Johnson County Clin-Trials, Inc.', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '40509', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Alliance for Multispeciality Research, LLC', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '78745', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Tekton Research Inc', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77901', 'city': 'Victoria', 'state': 'Texas', 'country': 'United States', 'facility': 'Crossroads Clinical Research (Victoria)', 'geoPoint': {'lat': 28.80527, 'lon': -97.0036}}, {'zip': '84109', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'J. Lewis Research, Inc. / Foothill Family Clinic South', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ModernaTX, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}