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Ignite Creation Date: 2025-12-24 @ 5:57 PM

Ignite Modification Date: 2025-12-29 @ 2:09 AM

Study NCT ID: NCT04732468

Status: TERMINATED

Last Update Posted: 2024-10-15

First Post: 2021-01-27

Is NOT Gene Therapy: True

Has Adverse Events: True

Brief Title: COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA

Sponsor:

Organization:

Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013535', 'term': 'Suspensions'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lennie.sender@immunitybio.com', 'phone': '855-797-9277', 'title': 'Lennie Sender, Chief Operating Officer', 'organization': 'Immunitybio'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to low enrollment.'}}, 'adverseEventsModule': {'timeFrame': 'Non-serious solicited AEs were to be recorded by the investigator for 7 days after each dose and non-serious unsolicited AEs were to be recorded from the time of first dose of study treatment until 30 days after the last dose of study treatment. All MAAEs, and SAEs were to be recorded by the investigator from the time of first dose of study treatment until 6 months after the last dose of study treatment.', 'description': 'For MAAEs/SAEs that were considered related to study treatment, those events were to be reported at any time regardless of last dose date or end of study visit date.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1:Cohort 1', 'description': 'Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group 1: Cohort 2', 'description': 'Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Group 1:Cohort 3', 'description': 'Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Group 1:Cohort 4', 'description': 'Solicited Local Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Group 2: Cohort 1', 'description': 'Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group 2: Cohort 2', 'description': 'Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 9, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Group 2: Cohort 3', 'description': 'Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Group 2: Cohort 4', 'description': 'Solicited Systemic Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Group 3:Cohort 1', 'description': 'Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Group 3: Cohort 2', 'description': 'Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Group 3: Cohort 3', 'description': 'Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'Group 3: Cohort 4', 'description': 'Unsolicited Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG012', 'title': 'Group 4: Cohort 1', 'description': 'Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG013', 'title': 'Group 4: Cohort 2', 'description': 'Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG014', 'title': 'Group 4: Cohort 3', 'description': 'Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG015', 'title': 'Group 4: Cohort 4', 'description': 'Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG016', 'title': 'Group 5: Cohort 1', 'description': 'Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 2, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG017', 'title': 'Group 5:Cohort 2', 'description': 'Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG018', 'title': 'Group 5: Cohort 3', 'description': 'Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 5, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG019', 'title': 'Group 5: Cohort 4', 'description': 'Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG020', 'title': 'Group 6: Cohort 1', 'description': 'Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG021', 'title': 'Group 6: Cohort 2', 'description': 'Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG022', 'title': 'Group 6: Cohort 3', 'description': 'Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG023', 'title': 'Group 6: Cohort 4', 'description': 'Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG024', 'title': 'Group 7: Cohort 1', 'description': 'Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG025', 'title': 'Group 7: Cohort 2', 'description': 'Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG026', 'title': 'Group 7:Cohort 3', 'description': 'Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG027', 'title': 'Group 7: Cohort 4', 'description': 'Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4}, {'groupId': 'EG025', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4}, {'groupId': 'EG025', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4}, {'groupId': 'EG025', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4}, {'groupId': 'EG025', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4}, {'groupId': 'EG025', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG027', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 8}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG025', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG026', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG027', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG004', 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'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG013', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG014', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG015', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG016', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG017', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG018', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG019', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG020', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG021', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG022', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG023', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG024', 'numAtRisk': 4}, {'groupId': 'EG025', 'numAtRisk': 10}, {'groupId': 'EG026', 'numAtRisk': 10}, {'groupId': 'EG027', 'numAtRisk': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of Solicited Local Reactogenicity AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)'}, {'type': 'PRIMARY', 'title': 'Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population is all subjects who received at least one dose of study intervention (safety analysis population)'}, {'type': 'PRIMARY', 'title': 'Incidence of Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Unsolicited Treatment-Related AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Unsolicited AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days post final vaccine', 'description': 'Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Unsolicited Treatment-Related AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 Days Post Final', 'description': 'Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of MAAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months post final vaccine administration', 'description': 'Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'OG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Months Post Final Vaccine', 'description': 'Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'FG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'FG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'FG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'BG001', 'title': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-SFusion+ N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'BG002', 'title': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'BG003', 'title': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for Injection) and hAd5-S-Fusion+N-ETSD (Oral Capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).\n\nhAd5-S-Fusion+N-ETSD (Suspension for injection): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.\n\nhAd5-SFusion+ N-ETSD (Oral capsule): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.2', 'spread': '8.18', 'groupId': 'BG000'}, {'value': '39.2', 'spread': '9.67', 'groupId': 'BG001'}, {'value': '42.2', 'spread': '10.75', 'groupId': 'BG002'}, {'value': '44.5', 'spread': '5.80', 'groupId': 'BG003'}, {'value': '41.8', 'spread': '9.24', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'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'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Healthy volunteers with a negative for SARS-CoV-2 test', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-31', 'size': 1623162, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-03-25T11:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'The study was terminated early due to low enrollment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2021-01-27', 'resultsFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-10', 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Solicited Local Reactogenicity AEs', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Solicited Local Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine'}, {'measure': 'Incidence of Solicited Systemic Treatment-Related Reactogenicity AEs', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Solicited Systemic Treatment-Related Reactogenicity Adverse Events Through 1 Week Post Final Vaccine Administration'}, {'measure': 'Incidence of Unsolicited AEs', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Unsolicited AEs Through 1 Week Post Final Vaccine Administration'}, {'measure': 'Incidence of Unsolicited Treatment-Related AEs', 'timeFrame': '1 week post final vaccine administration', 'description': 'Incidence of Unsolicited Treatment-Related Adverse Events Through 1 Week Post Final Vaccine Administration'}, {'measure': 'Incidence of Unsolicited AEs', 'timeFrame': '30 days post final vaccine', 'description': 'Incidence of Unsolicited Adverse Events Through 30 Days Post Final Vaccine Administration'}, {'measure': 'Incidence of Unsolicited Treatment-Related AEs', 'timeFrame': '30 Days Post Final', 'description': 'Incidence of Unsolicited Treatment-Related Adverse Events Through 30 Days Post Final Vaccine Administration'}, {'measure': 'Incidence of MAAEs', 'timeFrame': '6 Months post final vaccine administration', 'description': 'Incidence of Medically Attended Adverse Events Through 6 Months Post Final Vaccine Administration'}, {'measure': 'Incidence of Serious AEs', 'timeFrame': '6 Months Post Final Vaccine', 'description': 'Incidence of Serious Adverse Events Through 6 Months Post- Final Vaccine Administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19']}, 'descriptionModule': {'briefSummary': 'This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is designed to assess the safety, reactogenicity, and immunogenicity the combination of hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) and to select an optimal combination dose for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults, age 18 - 55 years, inclusive, at time of enrollment.\n2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.\n3. Agrees to the collection of biospecimens (eg, nasopharyngeal \\[NP\\] swabs) and venous blood per protocol.\n4. Ability to attend required study visits and return for adequate follow-up, as required by this protocol.\n5. Ability to swallow a capsule.\n6. Temperature \\< 38°C.\n7. Negative for SARS-CoV-2 (qPCR or LAMP test) and no known previous COVID-19 exposure or disease.\n8. Agreement to practice effective contraception for female subjects of childbearing potential and non-sterile males. Female subjects of childbearing potential must agree to use effective contraception while on study until at least 1 month after the last dose of vaccine. Non-sterile male subjects must agree to use a condom while on study until at least 1 month after the last dose of vaccine. Effective contraception includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier methods (eg, condom, diaphragm) used with spermicide, intrauterine devices (IUDs), oral contraceptives, and abstinence.\n\nExclusion Criteria:\n\n1. Allergy to any component of the investigational vaccine, or a more severe allergic reaction and history of allergies in the past.\n2. Pregnant and nursing women. A negative serum or urine pregnancy test during screening and on the day of and prior to each dose must be documented before the vaccine is administered to a female subject of childbearing potential.\n3. Live in a nursing home or long-term care facility.\n4. Chronic lung disease including chronic obstructive pulmonary disease (COPD) or moderate to severe asthma.\n5. Pulmonary fibrosis.\n6. Current or former smoker.\n7. Bone marrow or organ transplantation.\n8. Obesity (defined as body mass index \\[BMI\\] of 30 kg/m2 or higher).\n9. Diabetes.\n10. Chronic kidney disease.\n11. Liver disease.\n12. Sickle cell disease.\n13. Thalassemia.\n14. Doctors, nurses, first responders, and other healthcare workers working in direct contact with COVID-19 patients.\n15. Any disease associated with acute fever, or any infection.\n16. Self-reported history of severe acute respiratory syndrome (SARS).\n17. History of hepatitis B or hepatitis C.\n18. HIV or other acquired or hereditary immunodeficiency.\n19. Serious cardiovascular diseases, such as heart failure, coronary artery disease, cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary hypertension, severe hypertension without controllable drugs, etc.\n20. Cerebrovascular disease.\n21. Cystic fibrosis.\n22. Neurologic conditions, such as dementia.\n23. Hereditary or acquired angioneurotic edema.\n24. Urticaria in the last 12 months.\n25. No spleen or functional asplenia.\n26. Platelet disorder or other bleeding disorder that may cause injection contraindication.\n27. Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness within 3 months before administration of study vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.)\n28. Prior administration of blood products in last 4 months.\n29. Prior administration of other research medicines in last 1 month.\n30. Received or plans to receive an attenuated vaccine within 1 month before or after each study vaccination.\n31. Received or plans to receive an inactivated vaccine within 14 days before or after each study vaccination.\n32. Current treatment with investigational, authorized, or approved agents for prophylaxis of COVID-19.\n33. Have a household contact that has been diagnosed with COVID-19.\n34. Current anti-tuberculosis prophylaxis or therapy.\n35. Currently receiving treatment for cancer or history of cancer in the last five years (except basal cell carcinoma of the skin and cervical carcinoma in situ).\n36. According to the judgement of investigator, various medical, psychological, social or other conditions that could affect the subjects ability to sign informed consent.\n37. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.'}, 'identificationModule': {'nctId': 'NCT04732468', 'briefTitle': 'COVID-19 Oral and Subcutaneous Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenovirus Platform in Healthy Volunteers in USA', 'organization': {'class': 'INDUSTRY', 'fullName': 'ImmunityBio, Inc.'}, 'officialTitle': 'Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of Subcutaneously and Orally Administered Prophylactic Vaccination With 2nd Generation (E1/E2B/E3-Deleted) Adenoviral COVID-19 in Normal Healthy Volunteers', 'orgStudyIdInfo': {'id': 'COVID-4.005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)', 'description': 'For subjects in cohort 1, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Suspension for injection) again on day 22 (boost).', 'interventionNames': ['Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)', 'Drug: hAd5-SFusion+ N-ETSD (Oral capsule)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)', 'description': 'For subjects in cohort 2, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-S-Fusion+N-ETSD (Oral capsule) on day 22 (boost).', 'interventionNames': ['Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)', 'Drug: hAd5-SFusion+ N-ETSD (Oral capsule)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)', 'description': 'For subjects in cohort 3, hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on days 1 (prime) and on day 22 (boost).', 'interventionNames': ['Drug: hAd5-SFusion+ N-ETSD (Oral capsule)']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)', 'description': 'For subjects in cohort 4, hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule) were administered on day 1 (prime) and hAd5-SFusion+N-ETSD (Oral capsule) will be administered on days 15 (boost) and 22 (boost).', 'interventionNames': ['Biological: hAd5-S-Fusion+N-ETSD (Suspension for injection)', 'Drug: hAd5-SFusion+ N-ETSD (Oral capsule)']}], 'interventions': [{'name': 'hAd5-S-Fusion+N-ETSD (Suspension for injection)', 'type': 'BIOLOGICAL', 'description': 'The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.', 'armGroupLabels': ['Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)', 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)', 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)']}, {'name': 'hAd5-SFusion+ N-ETSD (Oral capsule)', 'type': 'DRUG', 'description': 'The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.', 'armGroupLabels': ['Cohort 1- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)', 'Cohort 2- hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-SFusion+ N-ETSD (Oral capsule)', 'Cohort 3 - hAd5-S-Fusion+N-ETSD (Oral capsule)', 'Cohort 4 - hAd5-S-Fusion+N-ETSD (Suspension for injection) and hAd5-S-Fusion+N-ETSD (Oral capsule)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90245', 'city': 'El Segundo', 'state': 'California', 'country': 'United States', 'facility': 'Chan Soon - Shiong Institute for Medicine', 'geoPoint': {'lat': 33.91918, 'lon': -118.41647}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ImmunityBio, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}