Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT04914520
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2021-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-21', 'studyFirstSubmitDate': '2021-05-19', 'studyFirstSubmitQcDate': '2021-05-31', 'lastUpdatePostDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Reporting Treatment-emergent Adverse Events', 'timeFrame': 'From first administration through 28 days post second administration'}, {'measure': 'Number of Participants Reporting Local and Systemic Adverse Events', 'timeFrame': 'From first administration up to 14 days after second administration'}, {'measure': 'Number of Participants Reporting Serious Adverse Events', 'timeFrame': 'From date of informed consent up to approximately 3 months'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Fold Rise (GMFR) of Anti-RSV Specific Neutralizing Activity', 'timeFrame': 'Day 29 and Day 57 post-dose and at the time of discontinuation (whichever occurs first), up to approximately 2 months'}, {'measure': 'Geometric Mean Titer (GMT) of Anti-VAGA-9001a IgG', 'timeFrame': 'Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months'}, {'measure': 'Geometric Mean Titer (GMT) of Anti-RSV IgG', 'timeFrame': 'Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months'}, {'measure': 'Number of IFN-γ spot-forming cells in PBMC Detected by ELISPOT', 'timeFrame': 'Day 1 (pre-dose), Day 29 and Day 57 post-dose, and at the time of discontinuation (whichever occurs first), up to approximately 2 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Respiratory Syncytial Virus Infections', 'VN0200'], 'conditions': ['Respiratory Syncytial Virus Infections']}, 'descriptionModule': {'briefSummary': 'This study will assess the safety, tolerability, and immunogenicity of VN-0200 after intramuscular injections in Japanese healthy adults and elderly subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese\n* Healthy adults aged ≥20 and ≤50 years (Step 1) or healthy elderly aged ≥65 and ≤80 years (at the time of informed consent)\n* Body mass index (BMI) is ≥18.0 and \\<30.0 kg/m\\^2 (at screening)\n\nExclusion Criteria:\n\n* Participants with a history of anaphylaxis or severe allergies due to food, medicine, insect bites, cosmetics, or vaccination\n* Having alcohol or drug dependence, etc.'}, 'identificationModule': {'nctId': 'NCT04914520', 'briefTitle': 'Study of VN-0200 in Japanese Healthy Adults and Elderly Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daiichi Sankyo'}, 'officialTitle': 'A Phase 1 Study to Assess the Safety, Tolerability, and Immunogenicity of VN-0200 After Intramuscular Injections in Japanese Healthy Adults and Elderly Subjects', 'orgStudyIdInfo': {'id': 'VN0200-A-J101'}, 'secondaryIdInfos': [{'id': 'jRCT2031210069', 'type': 'OTHER', 'domain': 'Japan Registry of Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Step 1: VN-0200 low dose', 'description': 'Healthy adults subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.', 'interventionNames': ['Biological: VN-0200']}, {'type': 'EXPERIMENTAL', 'label': 'Step 1: VN-0200 medium dose', 'description': 'Healthy adults subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.', 'interventionNames': ['Biological: VN-0200']}, {'type': 'EXPERIMENTAL', 'label': 'Step 1: VN-0200 high dose', 'description': 'Healthy adults subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.', 'interventionNames': ['Biological: VN-0200']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Step 1: Placebo', 'description': 'Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Step 2: VN-0200 low dose', 'description': 'Healthy elderly subjects will be randomized to receive intramuscular injection of low dose of VAGA-9001a adjuvanted with low dose of MABH-9002b.', 'interventionNames': ['Biological: VN-0200']}, {'type': 'EXPERIMENTAL', 'label': 'Step 2: VN-0200 dose medium dose', 'description': 'Healthy elderly subjects will be randomized to receive intramuscular injection of medium dose of VAGA-9001a adjuvanted with medium dose of MABH-9002b.', 'interventionNames': ['Biological: VN-0200']}, {'type': 'EXPERIMENTAL', 'label': 'Step 2: VN-0200 high dose', 'description': 'Healthy elderly subjects will be randomized to receive intramuscular injection of high dose of VAGA-9001a adjuvanted with high dose of MABH-9002b.', 'interventionNames': ['Biological: VN-0200']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Step 2: Placebo', 'description': 'Healthy adults and elderly subjects will be randomized to receive intramuscular injection of placebo.', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'VN-0200', 'type': 'BIOLOGICAL', 'description': 'VN-0200 (antigen: VAGA-9001a, adjuvant: MABH-9002b) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total', 'armGroupLabels': ['Step 1: VN-0200 high dose', 'Step 1: VN-0200 low dose', 'Step 1: VN-0200 medium dose', 'Step 2: VN-0200 dose medium dose', 'Step 2: VN-0200 high dose', 'Step 2: VN-0200 low dose']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total', 'armGroupLabels': ['Step 1: Placebo', 'Step 2: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160-0017', 'city': 'Shinjuku-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Medical Corporation Association Shinanokai Shinanozaka Clinic'}], 'overallOfficials': [{'name': 'Clinical Study Leader', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Daiichi Sankyo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daiichi Sankyo Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}