Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-29 @ 12:13 PM
Study NCT ID:
NCT04969250
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2021-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Vaccination for Recovered Inpatients With COVID-19 (VATICO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D045169', 'term': 'Severe Acute Respiratory Syndrome'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000090983', 'term': '2019-nCoV Vaccine mRNA-1273'}, {'id': 'D000090982', 'term': 'BNT162 Vaccine'}], 'ancestors': [{'id': 'D000087503', 'term': 'mRNA Vaccines'}, {'id': 'D000087504', 'term': 'Nucleic Acid-Based Vaccines'}, {'id': 'D014614', 'term': 'Vaccines, Synthetic'}, {'id': 'D011994', 'term': 'Recombinant Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000086663', 'term': 'COVID-19 Vaccines'}, {'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tico@insight-trials.org', 'phone': '612-626-9011', 'title': 'Melissa Skeans, Statistician/Protocol Manager', 'organization': 'University of Minnesota'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This trial anticipated enrolling 640 participants, but enrolled just 66.'}}, 'adverseEventsModule': {'timeFrame': '48 weeks', 'description': 'Participant who withdrew consent was not included in analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Acute chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aggravation of bicytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Recurrence of COVID-19 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3722', 'groupId': 'OG000', 'lowerLimit': '-0.0566', 'upperLimit': '0.8012'}, {'value': '0.5883', 'groupId': 'OG001', 'lowerLimit': '0.1366', 'upperLimit': '1.0399'}, {'value': '0.2088', 'groupId': 'OG002', 'lowerLimit': '-0.1758', 'upperLimit': '0.5935'}, {'value': '0.3073', 'groupId': 'OG003', 'lowerLimit': '-0.1479', 'upperLimit': '0.7624'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-vaccination baseline and 48 weeks post-vaccination', 'description': 'Change in antibody level as measured by ratio of follow-up to baseline level', 'unitOfMeasure': 'ratio of geometric mean responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.'}, {'type': 'SECONDARY', 'title': 'Ratio of 12-Week to Baseline Neutralizing Antibody (NAb) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4827', 'groupId': 'OG000', 'lowerLimit': '0.0641', 'upperLimit': '0.9014'}, {'value': '0.9206', 'groupId': 'OG001', 'lowerLimit': '0.4938', 'upperLimit': '1.3474'}, {'value': '0.2418', 'groupId': 'OG002', 'lowerLimit': '-0.1329', 'upperLimit': '0.6165'}, {'value': '0.6533', 'groupId': 'OG003', 'lowerLimit': '0.1554', 'upperLimit': '1.1513'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-vaccination baseline and 12 weeks post-vaccination', 'description': 'Change in antibody level as measured by ratio of follow-up to baseline level', 'unitOfMeasure': 'Ratio of geometric mean responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.'}, {'type': 'SECONDARY', 'title': 'Ratio of 24-Week to Baseline Neutralizing Antibody (NAb) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3002', 'groupId': 'OG000', 'lowerLimit': '-0.0453', 'upperLimit': '0.6458'}, {'value': '0.7747', 'groupId': 'OG001', 'lowerLimit': '0.4187', 'upperLimit': '1.1306'}, {'value': '0.2032', 'groupId': 'OG002', 'lowerLimit': '-0.1265', 'upperLimit': '0.5328'}, {'value': '0.3397', 'groupId': 'OG003', 'lowerLimit': '-0.0498', 'upperLimit': '0.7292'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-vaccination baseline and 24 weeks post-vaccination', 'description': 'Change in antibody level as measured by ratio of follow-up to baseline level', 'unitOfMeasure': 'Ratio of geometric mean responses', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.'}, {'type': 'SECONDARY', 'title': 'Number of Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through Week 24 after enrollment', 'description': 'Count of Deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N."}, {'type': 'SECONDARY', 'title': 'Number of Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.40', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Through Week 24', 'description': 'Count of SAEs', 'unitOfMeasure': 'SAEs', 'reportingStatus': 'POSTED', 'populationDescription': "Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N."}, {'type': 'SECONDARY', 'title': 'Number of Patients Non-adherent to 2nd Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.078', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Second vaccine doses were due at 4 and 16 weeks after randomization in Arm 2 and 4, respectively', 'description': 'Number of participants assigned a 2nd vaccine dose who did not receive it for any reason', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N."}, {'type': 'SECONDARY', 'title': 'Number of Patients Non-adherent to Assigned Treatment Strategy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.033', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Vaccine doses were due through 16-weeks post-randomization; participants were followed for vaccination status through 48 weeks post-randomization', 'description': 'Number of participants who received more or less vaccine than assigned, or who received vaccines at different time points than assigned', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Participant who withdrew consent was not included in analysis. Used Fisher's exact test rather than Chi-squared due to small N."}, {'type': 'SECONDARY', 'title': 'Percent of Patients With >=4-fold Difference in NAb', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'OG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '41.70', 'groupId': 'OG000'}, {'value': '53.30', 'groupId': 'OG001'}, {'value': '30.80', 'groupId': 'OG002'}, {'value': '27.30', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Pre-vaccination baseline and 48 weeks post-vaccination', 'description': 'Percentage of participants with \\>=4-fold change in NAb from baseline to 48 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient counts for this analysis are less than the total number of patients followed because some patients with follow-up visits did not have blood drawn.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'FG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'FG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'FG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The number of participants consented was not collected, so these numbers are the number of participants randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '66', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'BG001', 'title': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'BG002', 'title': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'id': 'BG003', 'title': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16\n\nModerna mRNA-1273 COVID-19 vaccine: 100 µg intramuscular injection\n\nPfizer BNT162b2 COVID-19 vaccine: 30 µg intramuscular injection'}, {'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': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '55', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '38', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Pacific Islander', 'categories': [{'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', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Only ethnicity reported', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-07', 'size': 884241, 'label': 'Study Protocol: Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-27T08:54', 'hasProtocol': True}, {'date': '2021-08-03', 'size': 164162, 'label': 'Study Protocol: Letter of Amendment', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-27T09:14', 'hasProtocol': True}, {'date': '2023-08-31', 'size': 110703, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_004.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-03-14T10:17', 'hasProtocol': False}, {'date': '2021-08-03', 'size': 213656, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_003.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-12-27T14:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2021-07-16', 'resultsFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2021-07-16', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-26', 'studyFirstPostDateStruct': {'date': '2021-07-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ratio of 48-Week to Baseline Neutralizing Antibody (NAb) Levels', 'timeFrame': 'Pre-vaccination baseline and 48 weeks post-vaccination', 'description': 'Change in antibody level as measured by ratio of follow-up to baseline level'}], 'secondaryOutcomes': [{'measure': 'Ratio of 12-Week to Baseline Neutralizing Antibody (NAb) Levels', 'timeFrame': 'Pre-vaccination baseline and 12 weeks post-vaccination', 'description': 'Change in antibody level as measured by ratio of follow-up to baseline level'}, {'measure': 'Ratio of 24-Week to Baseline Neutralizing Antibody (NAb) Levels', 'timeFrame': 'Pre-vaccination baseline and 24 weeks post-vaccination', 'description': 'Change in antibody level as measured by ratio of follow-up to baseline level'}, {'measure': 'Number of Deaths', 'timeFrame': 'Through Week 24 after enrollment', 'description': 'Count of Deaths'}, {'measure': 'Number of Serious Adverse Events (SAEs)', 'timeFrame': 'Through Week 24', 'description': 'Count of SAEs'}, {'measure': 'Number of Patients Non-adherent to 2nd Dose', 'timeFrame': 'Second vaccine doses were due at 4 and 16 weeks after randomization in Arm 2 and 4, respectively', 'description': 'Number of participants assigned a 2nd vaccine dose who did not receive it for any reason'}, {'measure': 'Number of Patients Non-adherent to Assigned Treatment Strategy', 'timeFrame': 'Vaccine doses were due through 16-weeks post-randomization; participants were followed for vaccination status through 48 weeks post-randomization', 'description': 'Number of participants who received more or less vaccine than assigned, or who received vaccines at different time points than assigned'}, {'measure': 'Percent of Patients With >=4-fold Difference in NAb', 'timeFrame': 'Pre-vaccination baseline and 48 weeks post-vaccination', 'description': 'Percentage of participants with \\>=4-fold change in NAb from baseline to 48 weeks'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'COVID 19', 'Coronaviridae Infections', 'Coronavirus Infections', 'RNA Virus Infections', 'Virus Diseases', 'Nidovirales Infections', 'SARS-CoV-2', 'SARS Coronavirus', 'VATICO', 'ACTIV-3', 'ACTIV3', 'TICO'], 'conditions': ['Covid19']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}, {'url': 'https://www.cdc.gov/coronavirus/2019-nCoV/index.html', 'label': 'CDC (Centers for Disease Control and Prevention): Coronavirus (COVID-19) website'}, {'url': 'https://www.niaid.nih.gov/clinical-trials/participant-guide', 'label': "A Participant's Guide to Clinical Trials (NIAID)"}, {'url': 'https://www.niaid.nih.gov/clinical-trials/find-a-clinical-trial', 'label': 'Find a Clinical Trial'}, {'url': 'https://www.niaid.nih.gov/clinical-trials', 'label': 'Clinical Trials at NIAID'}, {'url': 'https://www.niaid.nih.gov/', 'label': 'National Institute for Allergy and Infectious Diseases (NIAID)'}, {'url': 'https://www.who.int/emergencies/diseases/novel-coronavirus-2019/', 'label': 'WHO COVID-19 treatment guidelines'}]}, 'descriptionModule': {'briefSummary': 'In this Phase 4, open-label trial, participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still \\[TICO assignment\\] blinded and who are still within 28 to 90 days after initial TICO randomization, will be randomized in this 2x2 factorial design to one of four groups: (i) immediate versus 12 week deferral of first dose administration and also (ii) one dose only, versus two doses to be given 4 weeks apart of the Moderna mRNA-1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines).\n\nChoice of Moderna or Pfizer vaccine is determined based on availability at the site. The choice is individual, although participants vaccinated twice should receive the same type of vaccine for both injections. The primary objectives of this 2x2 factorial design are (i) to estimate the difference in neutralizing antibody (NAb) response to the mRNA vaccine from baseline to Week 48 among participants vaccinated early versus deferred, and (ii) to estimate the difference in NAb response to this vaccine among participants vaccinated once versus twice. The primary analyses will be carried out in participants randomized to placebo in TICO. Analyses will also be carried out for those who receive the investigational agent(s) studied in TICO.\n\nA key secondary objective is to ascertain the effect, if any, of SARS-CoV-2 monoclonal antibodies, and other interventions that have been studied in hospitalized COVID-19 subjects, on natural and vaccine-induced immunity.\n\nParticipants will remain blinded to the interventions received in the ACTIV-3/TICO study, however allocation to the timing of vaccination and to one or two vaccinations in this (VATICO) study is not blinded.', 'detailedDescription': "In this Phase 4 trial, participants in the TICO master protocol who received certain pre-specified blinded investigational agents or matched placebos will be offered enrollment, with the understanding that this will require 2X2 randomized assignment of the timing and of the number of mRNA SARS-CoV-2 vaccinations to be received, via publicly-available mRNA SARS-CoV-2 vaccination sites or via other routes, in keeping with the 4 specified study arm assignments.\n\nThis will address the objective of evaluating if the vaccine is best administered early or deferred after recovery, and whether one injection provides comparable immune response to a two-injection course of vaccination. Participants (as well as the protocol team) will remain blinded to the interventions studied in TICO. Allocation to timing of vaccination and to one or two vaccinations is not blinded. Participants will be offered enrollment in this protocol at the Day 28 or Day 90 visits in TICO, or anytime between these visits.\n\nParticipants will have blood collected for research purposes at the time of enrollment and at Weeks 12, 24, and 48.\n\nThe study vaccine and regimen will not be blinded; there will be be no 'dummy/placebo' vaccine administered. Vaccines are expected to be made available either through the study directly, or through a reliable public vaccination program using vaccine available per the local regulatory mechanism (e.g., currently under Emergency Use Authorization (EUA) for the United States) or via other routes in case such local mechanisms are not available.\n\nParticipants will be equally allocated to 4 groups to inform each of two vaccine strategies:\n\n* One injection versus two (for the immediate and deferred groups)\n* Immediate versus deferred (for one and two vaccinations)\n\nHence, the outcome of the randomization will lead to one of the four following vaccination strategies for each study participant:\n\nI1 - Immediate, one dose: vaccination at study entry only I2 - Immediate, two doses: vaccination at study entry and Week 4 D1 - Deferred, one dose: vaccination at Week 12 only D2 - Deferred, two doses: vaccination at Week 12 and Week 16\n\nRandomization will be stratified by study site and by randomization assignment in TICO for certain pre-specified investigational agents or their matching placebo.\n\nWhen addressing the two co-primary objectives, the following groups are combined:\n\n* Immediate vs deferred vaccine: groups I1 and I2 versus D1 and D2\n* One versus two vaccinations: groups I1 and D1 versus I2 and D2\n\nSimilar comparisons will be made separately for each of the two principal TICO arms, i.e., for those assigned to one of the investigational agents and for those assigned to the matching placebo. Both of these comparisons are protected by the randomization in the present study.\n\nGiven the factorial design, whether there is an interaction of one factor (timing of vaccination) with the other factor (number of doses) will need to be assessed although the study is not fully powered for this evaluation.\n\nA key secondary objective is to address whether the investigational agent studied in TICO (versus matching placebo) is affecting the primary outcome in this protocol. Of note, this comparison may not always be protected by randomization, as there may be differential inclusion in this protocol between those receiving the investigational agent in TICO and those receiving its matching placebo. This is more likely to be the case if the investigational agent is demonstrated to affect the chance of achieving sustained recovery.\n\nThe primary endpoint, immune response specific to the vaccination received, will be assessed at Week 48. Participants will have blood collected at time of enrollment, and at Weeks 12, 24 and 48 after study entry. Approximately 640 participants will be recruited. The total sample size will depend on how many investigational agents/placebo are evaluated in ACTIV-3/TICO."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participating in the ACTIV-3/TICO trial and received a selected blinded investigational agent, or placebo for that agent, at selected sites.\n* Willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration.\n* Participant is between Day 28 and Day 90 TICO visits inclusive at time of randomization.\n* At time of screening for this study, has experienced sustained recovery (i.e., the primary endpoint in TICO) for at least two consecutive weeks, i.e. having returned uninterrupted to the person's premorbid living facility (or equivalent) for at least 2 consecutive weeks.\n* Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.\n\nExclusion Criteria:\n\n* Receipt of a SARS-CoV-2 (COVID-19) vaccine after enrollment into TICO. Participants who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this study.\n* Known allergy to any component of the study eligible vaccine(s)."}, 'identificationModule': {'nctId': 'NCT04969250', 'briefTitle': 'Vaccination for Recovered Inpatients With COVID-19 (VATICO)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients', 'orgStudyIdInfo': {'id': '016 / VATICO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group I1', 'description': 'Immediate, one dose. Vaccination at study entry', 'interventionNames': ['Biological: Moderna mRNA-1273 COVID-19 vaccine', 'Biological: Pfizer BNT162b2 COVID-19 vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group I2', 'description': 'Immediate, two doses. Vaccination at study entry and Week 4', 'interventionNames': ['Biological: Moderna mRNA-1273 COVID-19 vaccine', 'Biological: Pfizer BNT162b2 COVID-19 vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D1', 'description': 'Deferred, one dose. Vaccination at Week 12 only', 'interventionNames': ['Biological: Moderna mRNA-1273 COVID-19 vaccine', 'Biological: Pfizer BNT162b2 COVID-19 vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D2', 'description': 'Deferred, two doses. Vaccination at Week 12 and Week 16', 'interventionNames': ['Biological: Moderna mRNA-1273 COVID-19 vaccine', 'Biological: Pfizer BNT162b2 COVID-19 vaccine']}], 'interventions': [{'name': 'Moderna mRNA-1273 COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': '100 µg intramuscular injection', 'armGroupLabels': ['Group D1', 'Group D2', 'Group I1', 'Group I2']}, {'name': 'Pfizer BNT162b2 COVID-19 vaccine', 'type': 'BIOLOGICAL', 'description': '30 µg intramuscular injection', 'armGroupLabels': ['Group D1', 'Group D2', 'Group I1', 'Group I2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center (Site 208-002), 8700 Beverly Blvd', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'San Francisco VAMC (Site 074-002), 4150 Clement Street', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospitals & Clinics (Site 203-003), Stanford University, School of Medicine, 300 Pasteur Dr., Grant Bldg, Room S011', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90502', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center (Site 066-002), 1124 W. Carson St., CDCRC', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80204', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Public Health Institute at Denver Health (Site 017-004), 660 Bannock Street', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20422', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington DC VA Medical Center (Site 009-004), 50 Irving Street, NW.', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33602', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Hillsborough County Health Department, University of South Florida (Site 032-001), 1105 E. Kennedy Blvd.', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis VA Medical Center (Site 105-001), 1 Veterans Drive', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital (Site 301-006), 2301 Erwin Road', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health (Site 210-001), Medical Center Boulevard', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Hospital (Site 080-036), 593 Eddy St.', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Miriam Hospital (Site 080-039), 164 Summit Ave.', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'CHRISTUS Spohn Shoreline Hospital (Site 080-001), 600 Elizabeth Street', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75235', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center (Site 084-001), 1936 Amelia Court, 2nd Floor', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Parkland Health and Hospital Systems (Site 084-002), James Aston Ambulatory Care Center - Clinical Research Unit, 5303 Harry Hines Blvd., Ste U-9.300', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '24153', 'city': 'Salem', 'state': 'Virginia', 'country': 'United States', 'facility': 'Salem VA Medical Center (Site 074-014), 1970 Roanoke Blvd.', 'geoPoint': {'lat': 37.29347, 'lon': -80.05476}}, {'city': 'Abuja', 'country': 'Nigeria', 'facility': 'Institute of Human Virology-Nigeria (Site 612-601), International Research Center of Excellence, Cadastral Zone COO Plot 62, after BAZE University, off CITEC Road', 'geoPoint': {'lat': 9.05785, 'lon': 7.49508}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital (Site 612-201), National Center for Infectious Diseases (NCID), 11 Jalan Tan Tock Seng', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Hospital Universitari Vall d'Hebron (Site 626-033), Passeig Vall Hebron, 119-129", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Clinic de Barcelona (Site 626-004), Carrer de Villaroel 170', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08916', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari Germans Trias i Pujol (Site 626-003) Carretera de Canyet, s/n', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Hospital Universitari Arnau de Vilanova (Site 026-035), Institut de Recerca Biomèdica de Lleida, Av. 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