Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 12:06 AM
Study NCT ID:
NCT05164094
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-15
First Post:
2021-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D007244', 'term': 'Infectious Mononucleosis'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 867}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-10-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-14', 'studyFirstSubmitDate': '2021-12-01', 'studyFirstSubmitQcDate': '2021-12-17', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)', 'timeFrame': 'Up to Day 176 (7-day follow-up after vaccination)'}, {'measure': 'Number of Participants with Unsolicited Adverse Events (AEs)', 'timeFrame': 'Up to Day 197 (28-day follow-up after vaccination)'}, {'measure': 'Number of Participants with SAEs, MAAEs, Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)', 'timeFrame': 'Day 1 to end of study (EOS) (Day 505)'}, {'measure': 'Number of Participants with Laboratory Abnormalities', 'timeFrame': 'Up to Day 176 (7-day follow-up after vaccination)'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)', 'timeFrame': 'Days 1, 85, and 197'}, {'measure': 'Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb', 'timeFrame': 'Days 1, 85, and 197'}, {'measure': 'Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs', 'timeFrame': 'Days 1, 85, and 197', 'description': 'The number of initially EBV-negative participants with seroconversion from below the lower limit of quantification (LLOQ) to above the LLOQ for EBV-specific (vaccine antigen) binding and nAbs responses and the initially EBV-positive participants with \\> 2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline (if above LLOQ) will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Infectious mononucleosis', 'Mononucleosis'], 'conditions': ['Epstein-Barr Virus Infection']}, 'descriptionModule': {'briefSummary': 'The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to \\<18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* According to the assessment of the investigator, is in good general health and can comply with study procedures.\n\nPart A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0).\n\nPart B:\n\nHealthy baseline EBV-seronegative adolescents from 12 to \\<18 years of age at the time of consent (Screening Visit, Day 0).\n\nPart C:\n\nHealthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).\n\nExclusion Criteria:\n\n* Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit.\n* Has symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the investigator).\n* Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.\n* Has a history of myocarditis, and/or pericarditis.\n* Has received or plans to receive any licensed or authorized vaccine, to include COVID-19 vaccines, ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection.\n\nNote: Other inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05164094', 'briefTitle': 'A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'ModernaTX, Inc.'}, 'officialTitle': 'A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults', 'orgStudyIdInfo': {'id': 'mRNA-1189-P101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: mRNA-1189 Dose Level 2', 'description': 'Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: mRNA-1189 Dose Level 3', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: mRNA-1189 Dose Level 4', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: mRNA-1189 Dose Level 1', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: mRNA-1189 Dose Level 2', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: mRNA-1189 Dose Level 3', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: mRNA-1189 Dose Level 4', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: mRNA-1189 Dose Level 1', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: mRNA-1189 Dose Level 2', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: mRNA-1189 Dose Level 3', 'description': 'Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.', 'interventionNames': ['Biological: mRNA-1189']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part C: Placebo', 'description': 'Participants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'mRNA-1189', 'type': 'BIOLOGICAL', 'description': 'Sterile liquid for injection', 'armGroupLabels': ['Part A: mRNA-1189 Dose Level 2', 'Part A: mRNA-1189 Dose Level 3', 'Part A: mRNA-1189 Dose Level 4', 'Part B: mRNA-1189 Dose Level 1', 'Part B: mRNA-1189 Dose Level 2', 'Part B: mRNA-1189 Dose Level 3', 'Part B: mRNA-1189 Dose Level 4', 'Part C: mRNA-1189 Dose Level 1', 'Part C: mRNA-1189 Dose Level 2', 'Part C: mRNA-1189 Dose Level 3']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': '0.9% sodium chloride (normal saline) injection', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo', 'Part C: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Medical Affiliated Research Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '85281', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Alliance for Multispecialty Research, LLC', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '92806', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Smart Cures Clinical Research', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92324', 'city': 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'responsibleParty': {'type': 'SPONSOR'}}}}