Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-30 @ 11:24 PM
Study NCT ID:
NCT04329104
Status:
COMPLETED
Last Update Posted:
2025-04-09
First Post:
2020-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008288', 'term': 'Malaria'}], 'ancestors': [{'id': 'D011528', 'term': 'Protozoan Infections'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000096724', 'term': 'Mosquito-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000719153', 'term': 'CIS43LS'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pcrompton@niaid.nih.gov', 'phone': '301-761-5042', 'title': 'Dr. Peter Crompton', 'organization': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 24 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 49, 'seriousNumAtRisk': 110, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 40, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Efficacy Study: Arm 3: Placebo', 'description': 'Participants receive placebo as one time intravenous infusion on Day 0.', 'otherNumAtRisk': 110, 'deathsNumAtRisk': 110, 'otherNumAffected': 61, 'seriousNumAtRisk': 110, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 17}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 12}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 19}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Visual Acuity Reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, 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{'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 14}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gingival 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'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Proctalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Strangulated Umbilical Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hernia Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'stats': [{'groupId': 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'EG003', 'numAtRisk': 110, 'numAffected': 45}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 40}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 51}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metrorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 14}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 25}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 32}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis Contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tooth Extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Venipuncture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thrombophlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Appendectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal Hernia Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Umbilical Hernia Repair', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypersplenism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 110, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 110, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 110, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Local Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}], 'classes': [{'title': 'Injection site swelling', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pain at injection site', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Tenderness at injection site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Redness at injection site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bruising at injection site', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Pruritus at injection site', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after administration of CIS43LS', 'description': 'Participants with incidence of local adverse events occurring within 7 days after administration of CIS43LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included all participants in the dose escalation study.'}, {'type': 'PRIMARY', 'title': 'Severity of Local Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after the administration of CIS43LS', 'description': 'The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials.\n\nGrade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity.\n\nGrade 2: Pain = Repeated use of non-narcotic pain reliever \\> 24 hours or interferes with daily activity; Tenderness = Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity.\n\nGrade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \\> 10 cm; Induration/Swelling = \\> 10 cm or prevents daily activity.\n\nGrade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; Induration/Swelling = Necrosis\n\nGrade 5: Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included all participants in the dose escalation study.'}, {'type': 'PRIMARY', 'title': 'Participants With Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}], 'classes': [{'title': 'Fever', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Feeling unusually tired or unwell', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Muscle aches', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Chills', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Joint pain', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after the administration of CIS43LS', 'description': 'Participants with incidence of systemic adverse events occurring within 7 days after product administration of CIS43LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included all participants in the dose escalation study.'}, {'type': 'PRIMARY', 'title': 'Severity of Systemic Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 days after the administration of CIS43LS', 'description': 'The severity of systemic AEs occurring after the administration of CIS43LS was assessed using the grading scale below:\n\nGrade 1: Fever = 37.5\\^oC-37.9\\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour\n\nGrade 2: Fever = 38\\^oC-38.4\\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \\> 24 hours or some interference with activity; Nausea = Some interference with activity or \\> 2 episodes/24 hours\n\nGrade 3: Fever = 38.5\\^oC-39.5\\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration\n\nGrade 4: Fever = \\> 39.5\\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock\n\nGrade 5: Death', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included all participants in the dose escalation study.'}, {'type': 'PRIMARY', 'title': 'Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Efficacy Study: Arm 3: Placebo', 'description': 'Participants receive placebo as one time intravenous infusion on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 7 through week 24 (168 days) after administration of intervention', 'description': 'Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until week 24.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included all participants in the efficacy study.'}, {'type': 'SECONDARY', 'title': 'Participants With Plasmodium Falciparum (Pf) Infection Detected by Reverse Transcription Polymerase Chain Reaction (RT-PCR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '110', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Efficacy Study: Arm 3: Placebo', 'description': 'Participants receive placebo as one time intravenous infusion on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 21 through week 24 (168 days) after administration of intervention', 'description': 'Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by reverse transcription polymerase chain reaction (RT-PCR) using dried blood spot specimen collected from participants from day 21 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until 24 weeks. Plasmodium 18S rRNA RT-PCR assay was applied to dried blood spots during analysis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis included all participants in the efficacy study.'}, {'type': 'SECONDARY', 'title': 'Maximum Serum Concentration (Cmax) for CIS43LS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '109', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG003', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG004', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '120.98', 'spread': '22.41', 'groupId': 'OG000'}, {'value': '280.52', 'spread': '40.56', 'groupId': 'OG001'}, {'value': '897.21', 'spread': '105.41', 'groupId': 'OG002'}, {'value': '239.62', 'spread': '62.77', 'groupId': 'OG003'}, {'value': '1033.63', 'spread': '286.52', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured through Week 24', 'description': 'Maximum serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration to assess durability of CIS43LS and allow for correlation with Plasmodium falciparum (Pf) infection risk. Cmax is the peak serum concentration that CIS43LS achieves after it has been administered. It is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group and measured by a Meso Scale Discovery LLC-based automation platform.', 'unitOfMeasure': 'µg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received CIS43LS, excluding placebo group.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Serum Concentration (Tmax) for CIS43LS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '109', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG003', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'OG004', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.561', 'spread': '0.040', 'groupId': 'OG000'}, {'value': '0.556', 'spread': '0.054', 'groupId': 'OG001'}, {'value': '0.583', 'spread': '0.033', 'groupId': 'OG002'}, {'value': '1.954', 'spread': '5.390', 'groupId': 'OG003'}, {'value': '0.597', 'spread': '0.115', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'One to 24 hours post-infusion', 'description': 'Time to maximum total serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration. Tmax is the time it takes to reach Cmax of CIS43LS after it has been administered; it is determined based on the summary PK curve for each dose group. This was calculated by subtracting the time the CIS43LS intravenous infusion was stopped from the time the blood was collected for the Cmax, at the post-one hour blood draw.', 'unitOfMeasure': 'Hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received CIS43LS, excluding placebo group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'FG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'FG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'FG003', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'FG004', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'FG005', 'title': 'Efficacy Study: Arm 3: Placebo', 'description': 'Participants receive placebo as one time intravenous infusion on Day 0.'}], 'periods': [{'title': 'Dose Escalation Study - 5 mg/kg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Dose Escalation Study - 10 mg/kg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Dose Escalation Study - 40 mg/kg', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Efficacy Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '110'}, {'groupId': 'FG004', 'numSubjects': '110'}, {'groupId': 'FG005', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '104'}, {'groupId': 'FG005', 'numSubjects': '102'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}, {'value': '348', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Dose-escalation Study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'BG001', 'title': 'Dose-escalation Study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'BG002', 'title': 'Dose-escalation Study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'BG003', 'title': 'Efficacy Study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'BG004', 'title': 'Efficacy Study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.'}, {'id': 'BG005', 'title': 'Efficacy Study: Arm 3: Placebo', 'description': 'Participants receive placebo as one time intravenous infusion on Day 0.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18-20 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}]}, {'title': '21-30 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '93', 'groupId': 'BG006'}]}]}, {'title': '31-40 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '39', 'groupId': 'BG003'}, {'value': '36', 'groupId': 'BG004'}, {'value': '41', 'groupId': 'BG005'}, {'value': '119', 'groupId': 'BG006'}]}]}, {'title': '41-50 years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '93', 'groupId': 'BG006'}]}]}, {'title': '51-55 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '149', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}, {'value': '66', 'groupId': 'BG005'}, {'value': '199', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black or African', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}, {'value': '348', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Mali', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '110', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}, {'value': '110', 'groupId': 'BG005'}, {'value': '348', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-13', 'size': 1013637, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-21T10:23', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 348}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2020-03-30', 'resultsFirstSubmitDate': '2024-04-03', 'studyFirstSubmitQcDate': '2020-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-03', 'studyFirstPostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Local Adverse Events (AEs)', 'timeFrame': 'Within 7 days after administration of CIS43LS', 'description': 'Participants with incidence of local adverse events occurring within 7 days after administration of CIS43LS. Local reactogenicity included pain/tenderness, swelling, redness, bruising, and pruritus at the site of infusion.'}, {'measure': 'Severity of Local Adverse Events (AEs)', 'timeFrame': 'Within 7 days after the administration of CIS43LS', 'description': 'The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials.\n\nGrade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity.\n\nGrade 2: Pain = Repeated use of non-narcotic pain reliever \\> 24 hours or interferes with daily activity; Tenderness = Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity.\n\nGrade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \\> 10 cm; Induration/Swelling = \\> 10 cm or prevents daily activity.\n\nGrade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; Induration/Swelling = Necrosis\n\nGrade 5: Death'}, {'measure': 'Participants With Systemic Adverse Events (AEs)', 'timeFrame': 'Within 7 days after the administration of CIS43LS', 'description': 'Participants with incidence of systemic adverse events occurring within 7 days after product administration of CIS43LS. Systemic reactogenicity events included fever, feeling unusually tired or unwell, muscle aches, headache, chills, nausea, and joint pain.'}, {'measure': 'Severity of Systemic Adverse Events (AEs)', 'timeFrame': 'Within 7 days after the administration of CIS43LS', 'description': 'The severity of systemic AEs occurring after the administration of CIS43LS was assessed using the grading scale below:\n\nGrade 1: Fever = 37.5\\^oC-37.9\\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour\n\nGrade 2: Fever = 38\\^oC-38.4\\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \\> 24 hours or some interference with activity; Nausea = Some interference with activity or \\> 2 episodes/24 hours\n\nGrade 3: Fever = 38.5\\^oC-39.5\\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration\n\nGrade 4: Fever = \\> 39.5\\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock\n\nGrade 5: Death'}, {'measure': 'Participants With Plasmodium Falciparum (Pf) Infection Detected by Microscopic Examination', 'timeFrame': 'Day 7 through week 24 (168 days) after administration of intervention', 'description': 'Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by microscopic examination of thick blood smear collected from participants from day 7 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until week 24.'}], 'secondaryOutcomes': [{'measure': 'Participants With Plasmodium Falciparum (Pf) Infection Detected by Reverse Transcription Polymerase Chain Reaction (RT-PCR)', 'timeFrame': 'Day 21 through week 24 (168 days) after administration of intervention', 'description': 'Number of participants with Plasmodium falciparum (Pf) blood stage infection defined as blood smear-positive for Pf was assessed by reverse transcription polymerase chain reaction (RT-PCR) using dried blood spot specimen collected from participants from day 21 through week 24 (168 days) after administration of CIS43LS or placebo. Sample was collected every two weeks until 24 weeks. Plasmodium 18S rRNA RT-PCR assay was applied to dried blood spots during analysis.'}, {'measure': 'Maximum Serum Concentration (Cmax) for CIS43LS', 'timeFrame': 'Measured through Week 24', 'description': 'Maximum serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration to assess durability of CIS43LS and allow for correlation with Plasmodium falciparum (Pf) infection risk. Cmax is the peak serum concentration that CIS43LS achieves after it has been administered. It is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group and measured by a Meso Scale Discovery LLC-based automation platform.'}, {'measure': 'Time to Maximum Serum Concentration (Tmax) for CIS43LS', 'timeFrame': 'One to 24 hours post-infusion', 'description': 'Time to maximum total serum concentration (Cmax) of CIS43LS by dose group following a single intravenous administration. Tmax is the time it takes to reach Cmax of CIS43LS after it has been administered; it is determined based on the summary PK curve for each dose group. This was calculated by subtracting the time the CIS43LS intravenous infusion was stopped from the time the blood was collected for the Cmax, at the post-one hour blood draw.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plasmodium Falciparum Infection', 'Malaria']}, 'referencesModule': {'references': [{'pmid': '36317783', 'type': 'RESULT', 'citation': 'Kayentao K, Ongoiba A, Preston AC, Healy SA, Doumbo S, Doumtabe D, Traore A, Traore H, Djiguiba A, Li S, Peterson ME, Telscher S, Idris AH, Kisalu NK, Carlton K, Serebryannyy L, Narpala S, McDermott AB, Gaudinski M, Traore S, Cisse H, Keita M, Skinner J, Hu Z, Zeguime A, Ouattara A, Doucoure M, Dolo A, Djimde A, Traore B, Seder RA, Crompton PD; Mali Malaria mAb Trial Team. Safety and Efficacy of a Monoclonal Antibody against Malaria in Mali. N Engl J Med. 2022 Nov 17;387(20):1833-1842. doi: 10.1056/NEJMoa2206966. Epub 2022 Oct 31.'}, {'pmid': '40461818', 'type': 'DERIVED', 'citation': 'Skinner J, Kayentao K, Ongoiba A, Healy SA, Hu Z, Preston AC, Niangaly A, Schwabl P, Cisse H, Doumbo S, Doumtabe D, Traore A, Li S, Peterson ME, Seilie AM, Chavtur C, Staubus W, Chang M, Kelley K, Traore H, Djiguiba A, Keita M, Ouattara A, Doucoure M, Keita M, Diarra D, Sylla M, Diakite D, Konate M, Traore S, Zeguime A, Dolo A, Neafsey DE, Murphy SC, Traore B, Seder RA, Crompton PD. Anti-sporozoite monoclonal antibody for malaria prevention: secondary efficacy outcome of a phase 2 randomized trial. Nat Med. 2025 Aug;31(8):2682-2690. doi: 10.1038/s41591-025-03739-y. Epub 2025 Jun 3.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, tolerability, and efficacy of VRC MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum (Pf) infection.', 'detailedDescription': 'This study will evaluate the safety, tolerability, and efficacy of VRC MALMAB0100-00-AB (CIS43LS), a human monoclonal antibody, against naturally occurring Plasmodium falciparum (Pf) infection.\n\nThe first part of the study is an open-label dose-escalation study for safety and tolerability. Participants will be assigned to one of three dose arms. Dosing will begin in the lowest dose arm. Once all participants in that arm reach Day 7 post-infusion, if no safety concerns have arisen, dosing will begin at the subsequent dose level. This process will be repeated until participants complete the third dose arm. Participants will be followed for safety to assess adverse events (AEs) at study visits 1, 3, 7, 14, 21, and 28 days after administration, then monthly through 24 weeks after administration.\n\nAfter the last subject in the highest dose arm reaches Day 7 safety follow-up, an interim safety evaluation will be performed before enrollment begins for the second part of the study.\n\nThe second part of the study is a randomized, double-blind, placebo-controlled trial to assess safety and protective efficacy of CIS43LS and placebo. Participants in the efficacy study will receive the study agent and be followed at study visits 1, 3, 7, 14, 21, and 28 days later, and once every 2 weeks thereafter through 24 weeks. Primary study assessments include physical examinations and blood collection for identification of Pf infection and other research laboratory evaluations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥18 and ≤55 years.\n* Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.\n* In good general health and without clinically significant medical history.\n* Able to provide informed consent.\n* Willing to have blood samples and data stored for future research.\n* Resides in or near Kalifabougou or Torodo, Mali, and available for the duration of the study.\n* Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study day 0 through the final study visit as described below.\n\n * Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device.\n * Nonchildbearing women will be required to report date of last menstrual period, history of surgical sterility (i.e., tubal ligation, hysterectomy) or premature ovarian insufficiency, and will have urine or serum pregnancy test performed per protocol.\n\nExclusion Criteria:\n\n* Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β-hCG) test (if female).\n* Currently breastfeeding.\n* Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol.\n* Study comprehension examination score of \\<80% correct or per investigator discretion.\n* Hemoglobin, white blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Subjects may be included at the investigator\'s discretion for "not clinically significant" values.)\n* Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator\'s discretion for "not clinically significant" values.)\n* Infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV).\n* Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.)\n* Clinically significant abnormal electrocardiogram (ECG; corrected QT interval \\[QTc\\] \\>460 or other significant abnormal findings, including unexplained tachycardia or bradycardia).\n* Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.\n* Receipt of any investigational product within the past 30 days.\n* Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. (Note: Past, current, or planned participation in observational studies is NOT exclusionary.)\n* Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.\n* History of a severe allergic reaction or anaphylaxis.\n* Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years).\n* Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren\'s syndrome, or autoimmune thrombocytopenia.\n* Known immunodeficiency syndrome.\n* Known asplenia or functional asplenia.\n* Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \\>10 mg/day) or immunosuppressive drugs within 30 days of day 0.\n* Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration.\n* Receipt of immunoglobulins and/or blood products within the past 6 months.\n* Previous receipt of an investigational malaria vaccine in the last 5 years.\n* Known allergies or contraindication against artemether-lumefantrine.\n* Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.'}, 'identificationModule': {'nctId': 'NCT04329104', 'briefTitle': 'Safety and Efficacy of CIS43LS Anti-malaria mAb in Mali', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'Safety and Efficacy of VRC-MALMAB0100-00-AB (CIS43LS), a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Dose-Escalation Trial and a Randomized, Double-Blind Trial of Adults in Mali', 'orgStudyIdInfo': {'id': '2020/32/CE/FMOS/FAPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-escalation study: Arm 1: 5 mg/kg of CIS43LS', 'description': 'Participants receive 5 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'interventionNames': ['Biological: VRC-MALMAB0100-00-AB (CIS43LS)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-escalation study: Arm 2: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'interventionNames': ['Biological: VRC-MALMAB0100-00-AB (CIS43LS)']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-escalation study: Arm 3: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'interventionNames': ['Biological: VRC-MALMAB0100-00-AB (CIS43LS)']}, {'type': 'EXPERIMENTAL', 'label': 'Efficacy study: Arm 1: 10 mg/kg of CIS43LS', 'description': 'Participants receive 10 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'interventionNames': ['Biological: VRC-MALMAB0100-00-AB (CIS43LS)']}, {'type': 'EXPERIMENTAL', 'label': 'Efficacy study: Arm 2: 40 mg/kg of CIS43LS', 'description': 'Participants receive 40 mg/kg of CIS43LS as one time intravenous infusion on Day 0.', 'interventionNames': ['Biological: VRC-MALMAB0100-00-AB (CIS43LS)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Efficacy study: Arm 3: Placebo', 'description': 'Participants receive placebo as one time intravenous infusion on Day 0.', 'interventionNames': ['Other: Normal saline']}], 'interventions': [{'name': 'VRC-MALMAB0100-00-AB (CIS43LS)', 'type': 'BIOLOGICAL', 'description': 'Administered via one-time intravenous infusion', 'armGroupLabels': ['Dose-escalation study: Arm 1: 5 mg/kg of CIS43LS', 'Dose-escalation study: Arm 2: 10 mg/kg of CIS43LS', 'Dose-escalation study: Arm 3: 40 mg/kg of CIS43LS', 'Efficacy study: Arm 1: 10 mg/kg of CIS43LS', 'Efficacy study: Arm 2: 40 mg/kg of CIS43LS']}, {'name': 'Normal saline', 'type': 'OTHER', 'description': 'Administered via one-time intravenous infusion', 'armGroupLabels': ['Efficacy study: Arm 3: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kalifabougou', 'state': 'Koulikoro', 'country': 'Mali', 'facility': 'Kalifabougou MRTC Clinic', 'geoPoint': {'lat': 12.94879, 'lon': -8.17437}}, {'city': 'Torodo', 'state': 'Koulikoro', 'country': 'Mali', 'facility': 'Torodo MRTC Clinic', 'geoPoint': {'lat': 12.8011, 'lon': -7.9496}}], 'overallOfficials': [{'name': 'Kassoum Kayentao, MD, MPH, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Faculté de Médecine Pharmacie d'Odontostomatologie (FMPOS)"}, {'name': 'Peter D. Crompton, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institutes of Health (NIH)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'collaborators': [{'name': 'Malaria Research and Training Center, Bamako, Mali', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}