Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT04075318
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2019-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of UB-312 in Healthy Participants and Parkinson's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@vaxxinity.com', 'phone': '254-244-5739', 'title': 'Executive Director, Clinical Development', 'organization': 'Vaxxinity, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected through the length of the participants enrollment in the study which was 44 weeks.', 'description': 'Definition does not differ.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: UB-312 40 mcg', 'description': 'UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part A: UB-312 100 mcg', 'description': 'UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part A: UB-312 40/300 mcg', 'description': 'UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part A: UB-312 300 mcg', 'description': 'UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part A: UB-312 40/1000 mcg', 'description': 'UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part A: UB-312 1000 mcg', 'description': 'UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part A: UB-312 2000 mcg', 'description': 'UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part A: Placebo', 'description': 'Placebo by intramuscular injection at Weeks 1, 5 and 13\n\nPlacebo: Matching placebo', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part B: UB-312 300/100 mcg', 'description': 'UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'Part B: UB-312 300 mcg', 'description': 'UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection\n\nUB-312: A synthetic peptide-based vaccine', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 7, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Part B: Placebo', 'description': 'Placebo by intramuscular injection at Weeks 1, 5 and 13\n\nPlacebo: Matching placebo', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eye Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG005', 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'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Immune System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections and Infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 9, 'numAffected': 4}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injury, Poisoning and Procedural Complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Muscoloskeletal and Connective Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nervous System Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 7, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 14, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal and Urinary Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory, Thoracic and Mediastinal Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin and Subcutaneous Tissue Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical and Medical Procedures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolism and Nutrition Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vascular Disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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{'value': '2', 'groupId': 'BG009'}, {'value': '1', 'groupId': 'BG010'}, {'value': '29', 'groupId': 'BG011'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '4', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '5', 'groupId': 'BG009'}, {'value': '5', 'groupId': 'BG010'}, {'value': '41', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Other', 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '2', 'groupId': 'BG011'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '66', 'groupId': 'BG011'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '1', 'groupId': 'BG011'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}, {'value': '7', 'groupId': 'BG008'}, {'value': '7', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '70', 'groupId': 'BG011'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-14', 'size': 399455, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-13T11:00', 'hasProtocol': True}, {'date': '2023-05-01', 'size': 2562483, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-13T11:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-28', 'studyFirstSubmitDate': '2019-08-05', 'resultsFirstSubmitDate': '2024-07-10', 'studyFirstSubmitQcDate': '2019-08-28', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-28', 'studyFirstPostDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Adverse Events', 'timeFrame': '44 weeks', 'description': 'Number of AEs will be assessed'}, {'measure': 'Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood', 'timeFrame': '44 weeks', 'description': 'Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45.'}, {'measure': 'Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF', 'timeFrame': '44 weeks', 'description': 'Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Parkinson's Disease", 'Parkinsonism']}, 'referencesModule': {'references': [{'pmid': '15755569', 'type': 'BACKGROUND', 'citation': 'Wang CY, Walfield AM. Site-specific peptide vaccines for immunotherapy and immunization against chronic diseases, cancer, infectious diseases, and for veterinary applications. Vaccine. 2005 Mar 18;23(17-18):2049-56. doi: 10.1016/j.vaccine.2005.01.007.'}, {'pmid': '17287052', 'type': 'BACKGROUND', 'citation': "Wang CY, Finstad CL, Walfield AM, Sia C, Sokoll KK, Chang TY, Fang XD, Hung CH, Hutter-Paier B, Windisch M. Site-specific UBITh amyloid-beta vaccine for immunotherapy of Alzheimer's disease. Vaccine. 2007 Apr 20;25(16):3041-52. doi: 10.1016/j.vaccine.2007.01.031. Epub 2007 Jan 19."}, {'pmid': '29067332', 'type': 'BACKGROUND', 'citation': "Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun."}, {'pmid': '38902546', 'type': 'RESULT', 'citation': 'Eijsvogel P, Misra P, Concha-Marambio L, Boyd JD, Ding S, Fedor L, Hsieh YT, Sun YS, Vroom MM, Farris CM, Ma Y, de Kam ML, Radanovic I, Vissers MFJM, Mirski D, Shareghi G, Shahnawaz M, Singer W, Kremer P, Groeneveld GJ, Yu HJ, Dodart JC. Target engagement and immunogenicity of an active immunotherapeutic targeting pathological alpha-synuclein: a phase 1 placebo-controlled trial. Nat Med. 2024 Sep;30(9):2631-2640. doi: 10.1038/s41591-024-03101-8. Epub 2024 Jun 20.'}, {'pmid': '35426173', 'type': 'RESULT', 'citation': 'Yu HJ, Thijssen E, van Brummelen E, van der Plas JL, Radanovic I, Moerland M, Hsieh E, Groeneveld GJ, Dodart JC. A Randomized First-in-Human Study With UB-312, a UBITh(R) alpha-Synuclein Peptide Vaccine. Mov Disord. 2022 Jul;37(7):1416-1424. doi: 10.1002/mds.29016. Epub 2022 Apr 15.'}]}, 'descriptionModule': {'briefSummary': "This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.", 'detailedDescription': "This is a first-in-human Phase 1 study to determine the safety, tolerability, and immunogenicity of UB-312 in healthy participants and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD.\n\nThe study consists of two parts. Part A of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part B of the study will consist of two cohorts of participants with Parkinson's disease (PD). Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female aged 40 to 85 years old, inclusive at screening\n* Expected to be able to undergo all study procedures\n* Other inclusion criteria apply\n\nFor Part B only:\n\n* A diagnosis of PD, confirmed by a neurologist\n* Hoehn \\&Yahr Stage ≤ III at Screening\n* Stable treatment of permitted antiparkinsonian medications from 30 days prior to first study drug administration or 60 days for MAO-B inhibitors, and expected to remain stable throughout the study\n\nExclusion Criteria:\n\n* Clinically significant abnormalities, as judged by the investigator\n* History of medical, neurological or psychiatric conditions which in the opinion of the investigator may compromise participant's safety or scientific value of the study\n* Acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)\n* History or evidence of an autoimmune disorder\n* History of anergy.\n* Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn\n* Other exclusion criteria apply\n\nFor Part B only:\n\n* Other known or suspected cause of Parkinsonism other than idiopathic PD\n* History or evidence at Screening of PD-related freezing episodes, falls, or orthostatic hypotension\n* Dopamine transporter single-photon emission computerized tomography scan (DaTscan) inconsistent with dopamine transporter deficit.\n* Clinically significant neurological disease other than PD"}, 'identificationModule': {'nctId': 'NCT04075318', 'briefTitle': "Study of UB-312 in Healthy Participants and Parkinson's Disease Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'United Neuroscience Ltd.'}, 'officialTitle': "A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants With Parkinson's Disease", 'orgStudyIdInfo': {'id': 'UB-312-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 40 mcg', 'description': 'UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 100 mcg', 'description': 'UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 40/300 mcg', 'description': 'UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 300 mcg', 'description': 'UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 40/1000 mcg', 'description': 'UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 1000 mcg', 'description': 'UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part A: UB-312 2000 mcg', 'description': 'UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: UB-312']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'Placebo by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: UB-312 300/100 mcg', 'description': 'UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection', 'interventionNames': ['Biological: UB-312']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: UB-312 300 mcg', 'description': 'UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection', 'interventionNames': ['Biological: UB-312']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Placebo by intramuscular injection at Weeks 1, 5 and 13', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'UB-312', 'type': 'BIOLOGICAL', 'description': 'A synthetic peptide-based vaccine', 'armGroupLabels': ['Part A: UB-312 100 mcg', 'Part A: UB-312 1000 mcg', 'Part A: UB-312 2000 mcg', 'Part A: UB-312 300 mcg', 'Part A: UB-312 40 mcg', 'Part A: UB-312 40/1000 mcg', 'Part A: UB-312 40/300 mcg', 'Part B: UB-312 300 mcg', 'Part B: UB-312 300/100 mcg']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Matching placebo', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Centre for Human Drug Research', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}], 'overallOfficials': [{'name': 'Medical Director, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Vaxxinity, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'United Neuroscience Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Centre for Human Drug Research, Netherlands', 'class': 'OTHER'}, {'name': 'Worldwide Clinical Trials', 'class': 'OTHER'}, {'name': 'Vaxxinity, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}