Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2026-01-02 @ 4:59 AM
Study NCT ID:
NCT04778904
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077594', 'term': 'Nivolumab'}, {'id': 'D012996', 'term': 'Solutions'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@barinthusbio.com', 'phone': '+44 (0) 1865 818 808', 'title': 'Chief Medical Officer', 'organization': 'Barinthus Biotherapeutics'}, 'certainAgreement': {'otherDetails': "There is an agreement restricting the right of the Participating Organisation and/or Principal Investigator to publish trial results, which may not be before the first multi-site publication. Following this, Participating Organisation and/or Principal Investigator may publish results, subject to Sponsor's prior review and comment (within 60 days). Sponsor can request a delay of publication up to six (6) months to enable protection of its proprietary information and/or IPR and know-how.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were collected from the time of Informed Consent signature by participants (up to 1.5 months prior to first dose) to End of Study (9 months from first dose), that is up 10.5 months', 'description': 'Adverse Events were recorded in the eCRF from the date the informed consent is signed, at all clinic visits to cover the period since the previous visit and during the visit.\n\nSerious adverse events and adverse events of special interest were recorded from the date the informed consent is signed until the end of the study or resolved or until participant contact discontinues', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 8, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 11, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fungal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Helicobacter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Laryngopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tooth Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cervical radiculopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': "Parkinson's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal distention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chronic gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Duodenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Intestinal metaplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Varices oesophageal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Night sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Hyperventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Weight increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Ligament sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tooth fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Rapid eye movement sleep behaviour disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Renal cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Heavy menstrual bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'seriousEvents': [{'term': 'RHEGMATOGENOUS RETINAL DETACHMENT OD (RIGHT EYE (OCULUS DEXTER)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'POLYPOSIS OVER RIGHT MAXILARY SINUSITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 9}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Incidence of vaccine related adverse events following vaccination', 'categories': [{'title': 'Participants experiencing events', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'No events', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 or greater vaccine related adverse events following vaccination', 'categories': [{'title': 'Participants experiencing events', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No events', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events vaccine related following vaccination', 'categories': [{'title': 'Participants experiencing events', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No events', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From each study vaccination for the following 27 days', 'description': 'The incidence of TEAEs and and ≥Grade 3 study vaccine-related adverse events will be based on the number and percentage of participants with events and number of events.\n\nTEAEs are defined as all adverse events occurring after study vaccine administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality.\n\nSeriousness of the TEAEs is assessed according to the published FDA criteria (2016).\n\nSeverity of the TEAEs will be graded according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials, 2007 (70 FR 22664).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set - all participants who received at least one vaccination.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'categories': [{'title': 'Participants experiencing events', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No events', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From each study vaccination with nivolumab for the following 27 days', 'description': 'The incidence of ≥Grade 3 adverse events will be based on the number and percentage of participants with events and number of events.\n\nTEAEs are defined as all adverse events occurring after study vaccine administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. ≥ Grade 3) according to FDA Guidance 70 FR 22664 and Causality.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one vaccination and nivolumab.'}, {'type': 'PRIMARY', 'title': 'The Incidence of Participants With Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'categories': [{'title': 'Participants with Adverse Events of Special Interest (AESI)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no AESI', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From study admission (the signature of informed consent) to the end of the study (Month 9)', 'description': 'The incidence of AESIs will be based on the number and percentage of participants with events and number of events.\n\nAESIs specific to this study include pneumonitis, grade 3 or 4 diarrhoea, diabetes, thyroid diseases, colitis, nephritis, immune-related endocrinopathies, myocarditis, immune-related skin conditions, or other unspecified immune-related adverse reactions.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set - all participants who received at least one vaccination'}, {'type': 'PRIMARY', 'title': 'The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'categories': [{'title': 'Participants experiencing events', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}, {'title': 'No events', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From each study vaccination for the following 27 days', 'description': 'The incidence of TEAEs will be based on the number and proportion of participants with events and number of events and will be calculated for each of the four study groups.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Haematology', 'categories': [{'title': 'Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Non Clinically Significant', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Biochemistry', 'categories': [{'title': 'Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Non Clinically Significant', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first vaccination until Month 9 (end of study)', 'description': 'The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant laboratory signs (haematology and biochemistry, including liver function tests) as assessed by the investigator.\n\nAll laboratory signs will be reported in SI units. If any laboratory sign is considered to be clinically significant i.e. outside laboratory normal reference range, the severity of this sign will be assessed according to the FDA Guidance for Industry 70 FR 22664. Absolute change, change from baseline and worst change for each participant will be calculated.\n\nThe incidence of participants with treatment-emergent, clinically significant laboratory signs and laboratory signs of Grade 3-4 severity will be calculated for each treatment group at each time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set - participants who received at least one vaccination'}, {'type': 'PRIMARY', 'title': 'Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Pulse Rate', 'categories': [{'title': 'Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Non Clinically Significant', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Blood Pressure', 'categories': [{'title': 'Clinically Significant', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Non Clinically Significant', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Temperature', 'categories': [{'title': 'Clinically Significant', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Non Clinically Significant', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first vaccination until Month 9 (end of study)', 'description': 'The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant vital signs.\n\nVital signs will be considered to be potentially clinically significant if they respectively fall below or above the relevant upper and lower limits.\n\nThe incidence of participants with treatment-emergent, clinically significant vital signs will be calculated for each treatment group at each time point.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set - participants who received at least one vaccination'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'WBC decrease', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'WBC increase', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes Decrease', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils Decrease', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Haemoglobin', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Platelets decrease', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Prothrombin time', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline till Month 9', 'description': 'Hematology laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).\n\nFor all hematology parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.\n\nThe number of participants showing shifts of at least two severity grades (as worst change from baseline for each hematology parameter) will be presented within shift tables.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis Plan changed analysis of laboratory results so that shift tables of laboratory results, vital signs, and physical examinations were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Alanine Aminotransferase', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Increase', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Blood Urea Nitrogen', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hypokalemia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hyperkalemia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hyponatremia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hypernatremia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hypoalbuminemia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline till Month 9', 'description': 'Biochemistry laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).\n\nFor all biochemistry parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.\n\nThe number of participants showing shifts of at least two severity grades (as worst change from baseline for each biochemistry parameter) will be presented within shift tables.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical analysis Plan has changed the planned analysis so that shift tables of laboratory results were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Bradycardia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Tachycardia', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hypotension', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension (Systolic)', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Hypertension (diastolic)', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Fever', 'categories': [{'title': 'Participants with at least two severity grades change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'Participants with no change', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline till Month 9', 'description': 'Worst change is defined as the lowest and highest post-baseline values for heart rate (bradycardia, tachycardia) and systolic blood pressure (hypotension, hypertension), and as the highest post-baseline values for diastolic blood pressure (hypertension) and temperature (fever).\n\nFor all vital signs measurements, changes from baseline will be calculated for each timepoint at which the vital sign measurement is conducted throughout the study.\n\nThe number of participants showing worst change from baseline for the vital signs parameters overall will be presented within shift tables.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Statistical Analysis Plan changed planned analysis so that shift tables of laboratory results, vital signs, and physical examinations were summarised using the worst post-baseline result overall, rather than by time point as indicated in the protocol.'}, {'type': 'SECONDARY', 'title': 'Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 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'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0068', 'groupId': 'OG000', 'lowerLimit': '-0.0030', 'upperLimit': '0.0315'}, {'value': '-0.0040', 'groupId': 'OG001', 'lowerLimit': '-0.0139', 'upperLimit': '0.0000'}, {'value': '0.0020', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0399'}, {'value': '-0.0162', 'groupId': 'OG003', 'lowerLimit': '-0.1309', 'upperLimit': '0.0072'}]}]}, {'title': 'CD4+ Change from Baseline to Day 28 (Pol 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0063', 'groupId': 'OG000', 'lowerLimit': '-0.0030', 'upperLimit': '0.0245'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0097', 'upperLimit': '0.0016'}, {'value': '0.0000', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0077'}, {'value': '-0.0155', 'groupId': 'OG003', 'lowerLimit': '-0.1436', 'upperLimit': '0.0193'}]}]}, {'title': 'CD4+ Change from Baseline to Day 35 (Pol 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0046', 'groupId': 'OG000', 'lowerLimit': '-0.0018', 'upperLimit': '0.0153'}, {'value': '0.0025', 'groupId': 'OG001', 'lowerLimit': '-0.0097', 'upperLimit': '0.0386'}, {'value': '0.0000', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0153'}, {'value': '-0.0162', 'groupId': 'OG003', 'lowerLimit': '-0.3456', 'upperLimit': '0.0201'}]}]}, {'title': 'CD4+ Change from Baseline to Month 3 (Pol 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0068', 'groupId': 'OG000', 'lowerLimit': '-0.0030', 'upperLimit': '0.0463'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0091', 'upperLimit': '0.0178'}, {'value': '0.0002', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0222'}, {'value': '-0.0149', 'groupId': 'OG003', 'lowerLimit': '-0.1094', 'upperLimit': '0.0485'}]}]}, {'title': 'CD4+ Change from Baseline to Month 6 (Pol 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0235', 'groupId': 'OG000', 'lowerLimit': '-0.0008', 'upperLimit': '0.0567'}, {'value': '0.0000', 'groupId': 'OG001', 'lowerLimit': '-0.0097', 'upperLimit': '0.0067'}, {'value': '0.0000', 'groupId': 'OG002', 'lowerLimit': '-0.0118', 'upperLimit': '0.0170'}, {'value': '-0.0196', 'groupId': 'OG003', 'lowerLimit': '-0.1050', 'upperLimit': '0.0555'}]}]}, {'title': 'CD4+ Change from Baseline to Month 9 (Pol 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0066', 'groupId': 'OG000', 'lowerLimit': '-0.0062', 'upperLimit': '0.1149'}, {'value': '-0.0011', 'groupId': 'OG001', 'lowerLimit': '-0.0101', 'upperLimit': '0.0147'}, {'value': '0.0000', 'groupId': 'OG002', 'lowerLimit': '0.0000', 'upperLimit': '0.0110'}, {'value': '-0.0155', 'groupId': 'OG003', 'lowerLimit': '-0.1639', 'upperLimit': '0.0054'}]}]}, {'title': 'CD4+ Change from Baseline to Day 7 (Pol 3+4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': 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'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0012', 'groupId': 'OG000', 'lowerLimit': '0.0000', 'upperLimit': '0.0897'}, {'value': '0.0195', 'groupId': 'OG001', 'lowerLimit': '-0.0221', 'upperLimit': '0.1407'}, {'value': '-0.0130', 'groupId': 'OG002', 'lowerLimit': '-0.1505', 'upperLimit': '0.1012'}, {'value': '0.0006', 'groupId': 'OG003', 'lowerLimit': '-0.1844', 'upperLimit': '0.1839'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9', 'description': 'The frequency of HBV-specific CD4+ and CD8+ T cells was determined by stimulating Peripheral Blood Mononuclear Cells (PBMC) with peptide pools corresponding to HBV antigens Core, Polymerase and Surface in an Intracellular Cytokine Staining (ICS) flow cytometry assay. In this assay the percentage of CD4+ or CD8+ expressing cytokines IFNγ, IL-2 or TNFα in response to HBV peptides is measured. Frequencies of antigen-specific cytokine-expressing CD4+ or CD8+ T cells are compared across trial timepoints and treatment groups.', 'unitOfMeasure': 'percentage of cells', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Immunogenicity Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reduction in HBsAg Titre', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Loss from Baseline to Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': '> 0.5 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '> 1.0 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No log change or <0.5 log10', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Loss from Baseline to Day 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': '> 0.5 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '> 1.0 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No log change or <0.5 log10', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Loss from Baseline to Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': '> 0.5 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '> 1.0 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No log change or <0.5 log10', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Loss from Baseline to Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': '> 0.5 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '> 1.0 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No log change or <0.5 log10', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Loss from Baseline to Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': '> 0.5 log10', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '> 1.0 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No log change or <0.5 log10', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Loss from Baseline to Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': '> 0.5 log10', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': '> 1.0 log10', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No log change or <0.5 log10', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9', 'description': 'This will be determined from samples of PBMCs. The percentage of participants with a HBsAg loss \\>0.5 log10 and \\>1.0 log10 will be determined for each vaccine and for each treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol population used for HBsAg changes'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg and HBeAg Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'HBsAg Seroconversion at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Seroconversion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}, {'title': 'No Seroconversion', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'HBeAg Seroconversion1 at Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'title': 'Seroconversion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'No Seroconversion', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Month 9', 'description': 'The proportion of participants infected with HBsAg-positive virus at baseline who develop Hepatitis B surface antigen antibody will be determined for each vaccine and for each treatment group.\n\nThe proportion of participants infected with HBeAg-positive virus at baseline who develop Hepatitis B e-antigen antibody will be determined for each vaccine and for each treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBsAg Seroconversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'categories': [{'title': 'No seroconversion (i.e., HBsAg > LLoQ) at Month 9', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}, {'title': 'Seroconversion (i.e., HBsAg < LLoQ) at Month 9', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Month 9', 'description': 'The proportion of participants infected with HBsAg-positive virus at baseline who become HBsAg negative will be determined for each vaccine and for each treatment group.\n\nThe times to seroconversion will be calculated in months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HBeAg Seroconversion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'categories': [{'title': 'Seroconversion', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': 'No Seroconversion', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline and Month 9', 'description': 'This will be determined from samples of PBMCs. The proportion of participants infected with HBeAg-positive virus at baseline who become HBeAg negative will be determined for each vaccine and for each treatment group.\n\nThe times to seroconversion will be calculated in months.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set The overall number of particpants analyized is made up of number of participants who are HBeAg positive at baseline and have non-missing HBeAg results at Month 9. This results in a smaller analysis population than the total participants for each group'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Reduction of Hepatitis B DNA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'OG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'OG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': 'No HBV DNA detected', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': '< 20 IU/mL HBV DNA detected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '≥ 20 IU/mL HBV DNA detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Day 35', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': 'No HBV DNA detected', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'title': '< 20 IU/mL HBV DNA detected', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}, {'title': '≥ 20 IU/mL HBV DNA detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': 'No HBV DNA detected', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': '< 20 IU/mL HBV DNA detected', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '≥ 20 IU/mL HBV DNA detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'title': 'No HBV DNA detected', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}, {'title': '< 20 IU/mL HBV DNA detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}, {'title': '≥ 20 IU/mL HBV DNA detected', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Day 35, Month 3 and Month 9', 'description': 'Changes from baseline will be calculated for each vaccine and for each treatment group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'FG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'FG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'FG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'BG001', 'title': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine'}, {'id': 'BG002', 'title': 'Group 3 (ChAdOx1-HBV, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'BG003', 'title': 'Group 4 (ChAdOx1-HBV and Nivolumab, MVA-HBV and Nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion\n\nChAdOx1-HBV: Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine\n\nMVA-HBV: Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine\n\nNivolumab: Human immunoglobulin G4 monoclonal antibody'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}]}, {'title': '>=65 years', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '42', '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': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '53', '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': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', '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': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'South Korea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set consisted of all participants who were randomised.\n\nSafety analysis set consisted of all participants who received at least 1 vaccination.\n\nPer-protocol (PP) analysis set consisted of all participants in the safety analysis set who received the correct trial vaccine and who had no major protocol deviations.\n\nImmunogenicity analysis set consisted of all participants in the PP set who had available immunogenicity data.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-09', 'size': 19295423, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-01-31T11:40', 'hasProtocol': True}, {'date': '2023-01-05', 'size': 25525489, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-01-31T11:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Participants are randomised to the four treatment groups, as the groups are initiated. Allocation to the groups is 1:1:1:1. Version 6.0 of the study protocol has closed Groups 1 and 4 to further randomisation; recruitment will now be in a 1:1 ratio between Groups 2 and 3 only.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2021-02-01', 'resultsFirstSubmitDate': '2024-02-05', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-12', 'studyFirstPostDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) and ≥Grade 3 Study Vaccine-related Adverse Events Following Study Vaccination', 'timeFrame': 'From each study vaccination for the following 27 days', 'description': 'The incidence of TEAEs and and ≥Grade 3 study vaccine-related adverse events will be based on the number and percentage of participants with events and number of events.\n\nTEAEs are defined as all adverse events occurring after study vaccine administration; they will be further categorised by Seriousness, Severity (i.e. ≥ Grade 3) and Causality.\n\nSeriousness of the TEAEs is assessed according to the published FDA criteria (2016).\n\nSeverity of the TEAEs will be graded according to the FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adults and Volunteers Enrolled in Preventative Vaccine Trials, 2007 (70 FR 22664).'}, {'measure': 'The Incidence of Participants With ≥Grade 3 Adverse Events Following Study Vaccination With Nivolumab', 'timeFrame': 'From each study vaccination with nivolumab for the following 27 days', 'description': 'The incidence of ≥Grade 3 adverse events will be based on the number and percentage of participants with events and number of events.\n\nTEAEs are defined as all adverse events occurring after study vaccine administration with nivolumab; they are further categorised by Seriousness, Severity (i.e. ≥ Grade 3) according to FDA Guidance 70 FR 22664 and Causality.'}, {'measure': 'The Incidence of Participants With Adverse Events of Special Interest (AESIs)', 'timeFrame': 'From study admission (the signature of informed consent) to the end of the study (Month 9)', 'description': 'The incidence of AESIs will be based on the number and percentage of participants with events and number of events.\n\nAESIs specific to this study include pneumonitis, grade 3 or 4 diarrhoea, diabetes, thyroid diseases, colitis, nephritis, immune-related endocrinopathies, myocarditis, immune-related skin conditions, or other unspecified immune-related adverse reactions.'}, {'measure': 'The Incidence of Participants With Treatment-Emergent Adverse Events (TEAEs) Within Each Study Group', 'timeFrame': 'From each study vaccination for the following 27 days', 'description': 'The incidence of TEAEs will be based on the number and proportion of participants with events and number of events and will be calculated for each of the four study groups.'}, {'measure': 'Incidence of Participants With Potentially Clinically Significant Laboratory Signs Within Each Treatment Group as Assessed by the Investigator', 'timeFrame': 'From the first vaccination until Month 9 (end of study)', 'description': 'The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant laboratory signs (haematology and biochemistry, including liver function tests) as assessed by the investigator.\n\nAll laboratory signs will be reported in SI units. If any laboratory sign is considered to be clinically significant i.e. outside laboratory normal reference range, the severity of this sign will be assessed according to the FDA Guidance for Industry 70 FR 22664. Absolute change, change from baseline and worst change for each participant will be calculated.\n\nThe incidence of participants with treatment-emergent, clinically significant laboratory signs and laboratory signs of Grade 3-4 severity will be calculated for each treatment group at each time point.'}, {'measure': 'Incidence of Participants With Potentially Clinically Significant Vital Signs Within Each Treatment Group as Assessed by the Investigator', 'timeFrame': 'From the first vaccination until Month 9 (end of study)', 'description': 'The incidence of participants will be based upon the number and proportion of patients in each treatment group with clinically significant vital signs.\n\nVital signs will be considered to be potentially clinically significant if they respectively fall below or above the relevant upper and lower limits.\n\nThe incidence of participants with treatment-emergent, clinically significant vital signs will be calculated for each treatment group at each time point.'}, {'measure': 'Number of Participants With Worst Changes From Baseline in Laboratory Hematology Parameters', 'timeFrame': 'From baseline till Month 9', 'description': 'Hematology laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).\n\nFor all hematology parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.\n\nThe number of participants showing shifts of at least two severity grades (as worst change from baseline for each hematology parameter) will be presented within shift tables.'}, {'measure': 'Number of Participants With Worst Changes From Baseline in Laboratory Biochemistry Parameters', 'timeFrame': 'From baseline till Month 9', 'description': 'Biochemistry laboratory values will be evaluated according to the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials (FDA).\n\nFor all biochemistry parameters, changes from baseline of at least two severity grades will be calculated for each timepoint at which the laboratory test is conducted throughout the study.\n\nThe number of participants showing shifts of at least two severity grades (as worst change from baseline for each biochemistry parameter) will be presented within shift tables.'}, {'measure': 'Number of Participants With Worst Changes From Baseline in Vital Signs Parameters (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure and Temperature)', 'timeFrame': 'From baseline till Month 9', 'description': 'Worst change is defined as the lowest and highest post-baseline values for heart rate (bradycardia, tachycardia) and systolic blood pressure (hypotension, hypertension), and as the highest post-baseline values for diastolic blood pressure (hypertension) and temperature (fever).\n\nFor all vital signs measurements, changes from baseline will be calculated for each timepoint at which the vital sign measurement is conducted throughout the study.\n\nThe number of participants showing worst change from baseline for the vital signs parameters overall will be presented within shift tables.'}], 'secondaryOutcomes': [{'measure': 'Frequency of HBV-specific CD4+ and CD8+ T Cells Induced by Each Treatment Regimen', 'timeFrame': 'Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9', 'description': 'The frequency of HBV-specific CD4+ and CD8+ T cells was determined by stimulating Peripheral Blood Mononuclear Cells (PBMC) with peptide pools corresponding to HBV antigens Core, Polymerase and Surface in an Intracellular Cytokine Staining (ICS) flow cytometry assay. In this assay the percentage of CD4+ or CD8+ expressing cytokines IFNγ, IL-2 or TNFα in response to HBV peptides is measured. Frequencies of antigen-specific cytokine-expressing CD4+ or CD8+ T cells are compared across trial timepoints and treatment groups.'}, {'measure': 'Percentage of Participants With Reduction in HBsAg Titre', 'timeFrame': 'Baseline, Day7, Day28, Day35, Month 3, Month 6, Month 9', 'description': 'This will be determined from samples of PBMCs. The percentage of participants with a HBsAg loss \\>0.5 log10 and \\>1.0 log10 will be determined for each vaccine and for each treatment group.'}, {'measure': 'Percentage of Participants With HBsAg and HBeAg Loss', 'timeFrame': 'Baseline, Month 9', 'description': 'The proportion of participants infected with HBsAg-positive virus at baseline who develop Hepatitis B surface antigen antibody will be determined for each vaccine and for each treatment group.\n\nThe proportion of participants infected with HBeAg-positive virus at baseline who develop Hepatitis B e-antigen antibody will be determined for each vaccine and for each treatment group.'}, {'measure': 'Percentage of Participants With HBsAg Seroconversion', 'timeFrame': 'Baseline and Month 9', 'description': 'The proportion of participants infected with HBsAg-positive virus at baseline who become HBsAg negative will be determined for each vaccine and for each treatment group.\n\nThe times to seroconversion will be calculated in months.'}, {'measure': 'Percentage of Participants With HBeAg Seroconversion', 'timeFrame': 'Baseline and Month 9', 'description': 'This will be determined from samples of PBMCs. The proportion of participants infected with HBeAg-positive virus at baseline who become HBeAg negative will be determined for each vaccine and for each treatment group.\n\nThe times to seroconversion will be calculated in months.'}, {'measure': 'Percentage of Participants With Reduction of Hepatitis B DNA', 'timeFrame': 'Baseline, Day 35, Month 3 and Month 9', 'description': 'Changes from baseline will be calculated for each vaccine and for each treatment group.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B']}, 'referencesModule': {'references': [{'pmid': '40932107', 'type': 'DERIVED', 'citation': 'Wang K, Shen Y, Hu C, Xu F, Wang Q, Gao Y, Zhou L. Population Pharmacokinetics and Exposure-Response Analysis of Serplulimab in Small Cell Lung Cancer Patients. Clin Transl Sci. 2025 Sep;18(9):e70322. doi: 10.1111/cts.70322.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label study to determine the safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV vaccines, with or without nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.', 'detailedDescription': 'This is a multi-centre study conducted in 52 participants, who will each be administered 2 vaccine injections (IM) on Day 0 and Day 28 as follows:\n\nGroup 1: MVA-HBV + MVA-HBV (now closed) Group 2: ChAdOx1-HBV + MVA-HBV Group 3: ChAdOx1-HBV + MVA-HBV + nivolumab (IV infusion) Group 4: ChAdOx1-HBV + nivolumab + MVA-HBV + nivolumab (now closed)\n\nParticipants are randomised to treatment as the groups are initiated with a 1:1:1:1 allocation. Version 6.0 of the study protocol has closed Groups 1 and 4 to further randomisation; recruitment will now be in a 1:1 ratio between Groups 2 and 3 only. A sentinel participant is dosed in Group 1, with further participants in Group 1 only being dosed at least 48h later. Group 2 is initiated following a Day 7 safety assessment of the first 6 participants in Group 1. Groups 3 and 4 are initiated following a Day 7 safety assessment of the first 6 participants in Group 2.\n\nThe primary objective of the study is to determine the safety and reactogenicity of the treatment regimens; this will be assessed by analysis of the incidence and severity of (serious) adverse events and any changes in laboratory values and vital signs.\n\nThe secondary objectives of the study are the determination of the immunogenicity of the ChAdOx1-HBV and MVA-HBV vaccines and the impact of PD-blockade, as well as the effect on HBV markers; these are assessed by measurements of the magnitude and avidity of HBV-specific CD4+ and CD8+ T cells and the magnitude of HBV markers.\n\nFollowing first vaccination, participants remain in the study for 9 months and attend clinic visits for vaccination and assessments on Days 0, 7, 28, 35 and Months, 3, 6 and 9.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adult males or females aged ≥18 to ≤65 years at screening (according to country/local regulations)\n2. BMI ≤32kg/m2\n3. Able to provide informed consent indicating they understand the purpose of, and procedures required, for the study and are willing to participate\n4. If female, willing not to become pregnant up to 8 weeks after last dose of study vaccine and up to 5 months after the last dose of nivolumab\n5. If female: Not pregnant or breast feeding and one of the following:\n\n * Of non-childbearing potential (i.e. women who have had a hysterectomy or tubal ligation or are post menopausal, as defined by no menses in ≥1 year and without an alternative medical cause)\n * Of childbearing potential but agrees to practice highly effective contraception for 4 weeks prior to study vaccine and 8 weeks after study vaccine and 5 months after the last dose of nivolumab. Highly effective methods of contraception include one or more of the following:\n\n (i) Male partner who is sterile (medically effective vasectomy) prior to the female participant's entry into the study and is the sole sexual partner for the female participant\n\n (ii) Combined (oestrogen and progestogen-containing) hormonal contraception associated with inhibition of ovulation:\n * oral\n * intravaginal\n * transdermal\n\n (iii) Progestogen-only hormonal contraception associated with inhibition of ovulation:\n * oral\n * injectable\n * implantable\n\n (iv) An intrauterine device\n\n (v) Bilateral tubal occlusion\n6. Documented evidence of chronic HBV infection (e.g. HBsAg positive ≥6 months with detectable HBsAg levels at screening)\n7. Receipt of only either entecavir, tenofovir (tenofovir alafenamide fumarate or tenofovir disoproxil fumarate), or besifovir for at least 12 months before screening\n8. Virally suppressed (HBV-DNA viral load \\< 40 IU/mL for ≥ 1 year)\n9. HBsAg levels \\<4000 IU/mL\n\nExclusion Criteria:\n\n1. Presence of any significant acute or chronic, uncontrolled medical/psychiatric illness\n2. Hepatitis C virus (HCV) antibody positive.\n3. HIV antibody positive\n4. Co-infection with hepatitis D virus\n5. Documented cirrhosis or advanced fibrosis indicated by a liver biopsy within 6 months prior to screening (Metavir activity grade A3 and stages F3 and F4; Ishak stages 4-6).\n\n In the absence of a documented liver biopsy, either 1 of the following (not both):\n * Screening Fibroscan with a result \\> 9 kilopascals (kPa) (or the equivalent) within ≤ 6 months of screening, OR\n * Screening FibroTest \\>0.48 and aspartate aminotransferase (AST) to platelet ratio index (APRI) of \\>1.\n6. ALT \\>3 x upper limit of normal (ULN), international normalized ratio (INR) \\>1.5 unless the participant was stable on an anticoagulant regimen affecting INR, albumin \\<3.5 g/dL, direct bilirubin \\>1.5 x ULN, platelet count \\< 100,000/microlitre.\n7. A history of liver decompensation (e.g. ascites, encephalopathy or variceal haemorrhage)\n8. Prior hepatocellular carcinoma\n9. Chronic liver disease of a non-HBV aetiology\n10. History or evidence of autoimmune disease or known immunodeficiency of any cause\n11. Presence of active infection\n12. Evidence of interstitial lung disease, active pneumonitis, myocarditis, or a history of myocarditis\n13. Past history of thyroid disorder or abnormal thyroid function at screening that is still active and uncontrolled\n14. Prolonged therapy with immunomodulators (e.g. corticosteroids such as prednisone \\> 10 mg/day) or biologics (e.g. monoclonal antibodies, IFN) within 3 months of screening\n15. Receipt of immunoglobulin or other blood products within 3 months prior to enrolment\n16. Receipt of any investigational drug or vaccine within 3 months prior to screening\n17. Receipt of any adenoviral-based vaccine within 3 months prior to administration of ChAdOx1-HBV on Day 0, or plan to receive an adenoviral-based vaccine within 3 months after Day 0\n18. Receipt of any live vaccines within 30 days prior to screening\n19. Receipt of any inactivated vaccines within 14 days prior to screening,\n20. History of severe hypersensitivity or anaphylactic reactions likely to be exacerbated by any component of the vaccine or nivolumab\n21. Malignancy within 5 years prior to screening with the exception of specific cancers that are cured by surgical resection (e.g. except basal cell skin carcinoma of the skin and cervical carcinoma). Participants under evaluation for possible malignancy are not eligible\n22. Current alcohol or substance abuse judged by the Investigator to potentially interfere with participant safety and compliance\n23. Significant cardiac disease or unstable uncontrolled cardiac disease\n24. Any laboratory test which is abnormal, and which is deemed by the Investigator to be clinically significant\n25. Cytotoxic agents, other anti HBV or traditional herbal medicines which, in the opinion of the Investigator, may have activity against HBV within the previous 6 months prior to randomization\n26. Any other finding that, in the opinion of the Investigator, deems the participant unsuitable for the study"}, 'identificationModule': {'nctId': 'NCT04778904', 'briefTitle': 'First-In-Human Study of ChAdOx1-HBV & MVA-HBV Vaccines (VTP-300) for Chronic HBV', 'organization': {'class': 'INDUSTRY', 'fullName': 'Barinthus Biotherapeutics'}, 'officialTitle': 'A Phase 1b/2a, Open-Label Study to Evaluate the Safety, Tolerability and Immunogenicity of VTP-300 With or Without Nivolumab in Participants With Chronic Hepatitis B Infection', 'orgStudyIdInfo': {'id': 'HBV-002'}, 'secondaryIdInfos': [{'id': '2020-000190-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (MVA-HBV)', 'description': 'Day 0: MVA-HBV 1 x 10\\^8 pfu IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection', 'interventionNames': ['Biological: MVA-HBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection', 'interventionNames': ['Biological: ChAdOx1-HBV', 'Biological: MVA-HBV']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (ChAdOx1-HBV, MVA-HBV and nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion', 'interventionNames': ['Biological: ChAdOx1-HBV', 'Biological: MVA-HBV', 'Biological: Nivolumab']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 (ChAdOx1-HBV and nivolumab, MVA-HBV and nivolumab)', 'description': 'Day 0: ChAdOx1-HBV 1 x 2.5 10\\^10 vp IM injection + nivolumab 0.3 mg/kg IV infusion Day 28: MVA-HBV 1 x 10\\^8 pfu IM injection + nivolumab 0.3 mg/kg IV infusion', 'interventionNames': ['Biological: ChAdOx1-HBV', 'Biological: MVA-HBV', 'Biological: Nivolumab']}], 'interventions': [{'name': 'ChAdOx1-HBV', 'type': 'BIOLOGICAL', 'description': 'Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine', 'armGroupLabels': ['Group 2 (ChAdOx1-HBV, MVA-HBV)', 'Group 3 (ChAdOx1-HBV, MVA-HBV and nivolumab)', 'Group 4 (ChAdOx1-HBV and nivolumab, MVA-HBV and nivolumab)']}, {'name': 'MVA-HBV', 'type': 'BIOLOGICAL', 'description': 'Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine', 'armGroupLabels': ['Group 1 (MVA-HBV)', 'Group 2 (ChAdOx1-HBV, MVA-HBV)', 'Group 3 (ChAdOx1-HBV, MVA-HBV and nivolumab)', 'Group 4 (ChAdOx1-HBV and nivolumab, MVA-HBV and nivolumab)']}, {'name': 'Nivolumab', 'type': 'BIOLOGICAL', 'otherNames': ['Opdivo 10mg/ml concentrate for solution for infusion'], 'description': 'Human immunoglobulin G4 monoclonal antibody', 'armGroupLabels': ['Group 3 (ChAdOx1-HBV, MVA-HBV and nivolumab)', 'Group 4 (ChAdOx1-HBV and nivolumab, MVA-HBV and nivolumab)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '492421', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Pusan National University Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '42601', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Centre', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '06591', 'city': 'Seoul', 'country': 'South Korea', 'facility': "The Catholic University of Korea Seoul Saint Mary's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '62247', 'city': 'Dalin', 'state': 'Chia-Yi County', 'country': 'Taiwan', 'facility': 'Buddhist Tzu Chi Medical Foundation', 'geoPoint': {'lat': 22.59516, 'lon': 120.30341}}, {'zip': '82445', 'city': 'Kaohsiung City', 'state': 'Yan-chao District', 'country': 'Taiwan', 'facility': 'E-Da Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '60002', 'city': 'Chiayi City', 'country': 'Taiwan', 'facility': 'Chia-Yi Christian Hospital', 'geoPoint': {'lat': 23.47917, 'lon': 120.44889}}, {'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': 'NG7 2UH', 'city': 'Nottingham', 'state': 'Notts', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': "King's College Hospital NHS Foundation Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barinthus Biotherapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}