Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT04152161
Status:
TERMINATED
Last Update Posted:
2025-06-19
First Post:
2019-10-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@gatesmri.org', 'phone': '+1 857 702 2108', 'title': 'Study Director', 'organization': 'Gates MRI'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Solicited AEs (comprising of injection site pain, redness, swelling, headache, fatigue, gastrointestinal symptoms, and fever) were recorded on diary cards (systematic assessment) for 7 days after vaccination. Solicited events ongoing at Day 7 were also recorded as unsolicited AEs. Unsolicited AEs were collected through Day 28, SAEs and All-cause mortality through Month 6 and Serious adverse drug reactions (ADRs) through Month 48.', 'description': 'Serious adverse events and non-serious adverse events were collected in Safety Population. An AE was classified as solicited if it was proactively recorded through a structured assessment (e.g., diary card) through 7 days post vaccination. Unsolicited AEs collected outside the daily card were presented separately. A participant who had a solicited event that was ongoing at Day 7 would have the event counted as both a solicited AE and an unsolicited AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.', 'otherNumAtRisk': 918, 'deathsNumAtRisk': 918, 'otherNumAffected': 800, 'seriousNumAtRisk': 918, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.', 'otherNumAtRisk': 917, 'deathsNumAtRisk': 917, 'otherNumAffected': 540, 'seriousNumAtRisk': 917, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Gastrointestinal Symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 136}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 140}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 657}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 248}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 381}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 148}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 349}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 111}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 229}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 184}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 27}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 195}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 164}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 27}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'seriousEvents': [{'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Subperiosteal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Intentional overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Meningitis tuberculous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Fibula fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}, {'term': 'Traumatic haemothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 918, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 917, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 27.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '871', 'groupId': 'OG000'}, {'value': '849', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.049', 'ciLowerLimit': '-0.431', 'ciUpperLimit': '0.230', 'estimateComment': 'Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.049', 'ciLowerLimit': '0.770', 'ciUpperLimit': '1.431', 'estimateComment': 'Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \\>14 years) as stratification variables.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The 1-sided p-value from the log-rank test was stratified by sex and age group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 months', 'description': 'Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intention to Treat Efficacy Population comprised of all participants randomly assigned to study intervention who received the study intervention, and are QFT negative at the Day 71 visit, or at the first study visit post Day 71 for which a QFT result is available if the Day 71 study visit was missed or the Day 71 QFT result was not available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early', 'denoms': [{'units': 'Participants', 'counts': [{'value': '871', 'groupId': 'OG000'}, {'value': '849', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.009', 'ciLowerLimit': '-0.395', 'ciUpperLimit': '0.270', 'estimateComment': 'Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5224', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.009', 'ciLowerLimit': '0.730', 'ciUpperLimit': '1.395', 'estimateComment': 'Hazard ratio was calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \\>14 years) as stratification variables.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The 1-sided p-value from the log-rank test was stratified by sex and age group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '36 Months Follow-up', 'description': 'Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early', 'denoms': [{'units': 'Participants', 'counts': [{'value': '871', 'groupId': 'OG000'}, {'value': '849', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 milliliter (mL) volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine Efficacy', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.049', 'ciLowerLimit': '-0.431', 'ciUpperLimit': '0.230', 'estimateComment': 'Vaccine Efficacy (VE) = 1 - Hazard Ratio, with 95%CI equal to (VE lower limit, VE upper limit) = (1 - Hazard Ratio upper limit, 1 - Hazard Ratio lower limit)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.049', 'ciLowerLimit': '0.770', 'ciUpperLimit': '1.431', 'estimateComment': 'Calculated using a stratified Cox proportional hazards model, with sex and age group (10-11 years, 12-14 years, and \\>14 years) as stratification variables.', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The 1-sided p-value from the log-rank test was stratified by sex and age group.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '48 Months Follow-up', 'description': 'Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'title': 'Any injection site symptom', 'categories': [{'measurements': [{'value': '754', 'groupId': 'OG000'}, {'value': '381', 'groupId': 'OG001'}]}]}, {'title': 'Any general body symptom', 'categories': [{'measurements': [{'value': '371', 'groupId': 'OG000'}, {'value': '314', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 7', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined as events that participants were specifically asked about and which were noted by participants in the diary card. Solicited AEs included injection site symptoms of injections site pain, redness and swelling and general body symptoms such as headache, fatigue, gastrointestinal symptoms, and fever.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '185', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 through Day 28', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary card, as well as solicited AEs that were ongoing at Day 7 after vaccination. Number of Participants With Unsolicited AEs Through 28 Days after vaccination has been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs of Special Interest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'title': 'Injection site abscess', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Suppurative lymphadenitis (Lymphadenitis bacterial)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Anaphylactic reaction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Disseminated BCG disease', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Osteomyelitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site lupus vulgaris', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Injection site keloid formation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Osteitis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 6 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AE of special interest are AEs that the sponsor closely monitors. The AEs of special interest to be collected and reported include immune system disorders (anaphylactic reaction), general disorders (disseminated BCG disease), infections and infestations (osteomyelitis, suppurative lymphadenitis, injection site abscess), skin and subcutaneous tissue disorders (injection site lupus vulgaris, injection site keloid formation), and bone disorders (osteitis).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Drug Reactions (ADRs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'OG000'}, {'value': '917', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'OG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. When an AE is judged to be serious and related to an investigational product, it is a Serious ADR.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 milliliter (mL) volume of BCG vaccine Statens Serum Institut (SSI), administered intradermally in deltoid region of the upper arm.'}, {'id': 'FG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '919'}, {'groupId': 'FG001', 'numSubjects': '917'}]}, {'type': 'Did Not Receive the Intervention', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '111'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '809'}, {'groupId': 'FG001', 'numSubjects': '806'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'Sponsor termination of study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '750'}, {'groupId': 'FG001', 'numSubjects': '755'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '18'}]}]}], 'recruitmentDetails': 'This was a Phase IIb, randomized, placebo-controlled, observer-blind study to evaluate the efficacy, safety, and immunogenicity of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.', 'preAssignmentDetails': 'A total of 1836 participants were enrolled from South African and were randomized 1:1 to experimental and placebo groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '918', 'groupId': 'BG000'}, {'value': '917', 'groupId': 'BG001'}, {'value': '1835', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bacille Calmette Guerin (BCG) Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.'}, {'id': 'BG001', 'title': 'Placebo Group', 'description': 'Participants were randomized to receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'spread': '1.68', 'groupId': 'BG000'}, {'value': '13.4', 'spread': '1.67', 'groupId': 'BG001'}, {'value': '13.4', 'spread': '1.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '474', 'groupId': 'BG000'}, {'value': '469', 'groupId': 'BG001'}, {'value': '943', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '444', 'groupId': 'BG000'}, {'value': '448', 'groupId': 'BG001'}, {'value': '892', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '625', 'groupId': 'BG000'}, {'value': '627', 'groupId': 'BG001'}, {'value': '1252', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '292', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '582', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black', 'categories': [{'measurements': [{'value': '729', 'groupId': 'BG000'}, {'value': '735', 'groupId': 'BG001'}, {'value': '1464', 'groupId': 'BG002'}]}]}, {'title': 'Asian Indian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Mixed Race', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}, {'title': 'Southern African Colored', 'categories': [{'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '245', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population comprises of all participants who received the study intervention.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-21', 'size': 14738178, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-12T15:37', 'hasProtocol': True}, {'date': '2023-10-16', 'size': 915518, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-12T15:41', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1836}}, 'statusModule': {'whyStopped': 'Sponsor decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2019-10-22', 'resultsFirstSubmitDate': '2025-05-12', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-04', 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Sustained QuantiFERON®-TB Gold Plus Assay (QFT) Conversion From a Negative to Positive Test Based on Positive QFT Test Results', 'timeFrame': 'Up to 48 months', 'description': 'Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 36-Months Follow-up or Discontinued Early', 'timeFrame': '36 Months Follow-up', 'description': 'Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.'}, {'measure': 'Number of Participants With Sustained QFT Conversion From a Negative to Positive Test Based on Positive QFT Test Results at 48-Months Follow-up or Discontinued Early', 'timeFrame': '48 Months Follow-up', 'description': 'Sustained conversion was defined as sustained QFT conversion from a negative to positive test, with initial conversion at any time after a first negative QFT result post randomization (Day 71 or subsequent visit if Day 71 result was not available), and remaining QFT positive at 3- and 6-months post-conversion.'}, {'measure': 'Number of Participants With Serious and Non-serious Solicited Adverse Events (AEs) Through 7 Days Post Vaccination', 'timeFrame': 'Day 1 through Day 7', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Solicited AEs were defined as events that participants were specifically asked about and which were noted by participants in the diary card. Solicited AEs included injection site symptoms of injections site pain, redness and swelling and general body symptoms such as headache, fatigue, gastrointestinal symptoms, and fever.'}, {'measure': 'Number of Participants With Unsolicited AEs Through Day 28, as Well as Solicited AEs That Were Ongoing at Day 7 After Vaccination', 'timeFrame': 'Day 1 through Day 28', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An AE does not necessarily have a causal relationship with the intervention. Unsolicited AEs were all AEs for which the participants were not specifically questioned in the participant diary card, as well as solicited AEs that were ongoing at Day 7 after vaccination. Number of Participants With Unsolicited AEs Through 28 Days after vaccination has been presented.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 6 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment. Number of Participants reporting SAEs has been presented.'}, {'measure': 'Number of Participants With AEs of Special Interest', 'timeFrame': 'Up to 6 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. AE of special interest are AEs that the sponsor closely monitors. The AEs of special interest to be collected and reported include immune system disorders (anaphylactic reaction), general disorders (disseminated BCG disease), infections and infestations (osteomyelitis, suppurative lymphadenitis, injection site abscess), skin and subcutaneous tissue disorders (injection site lupus vulgaris, injection site keloid formation), and bone disorders (osteitis).'}, {'measure': 'Number of Participants With Serious Adverse Drug Reactions (ADRs)', 'timeFrame': 'Up to 48 months', 'description': 'An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. When an AE is judged to be serious and related to an investigational product, it is a Serious ADR.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mycobacterium tuberculosis infection', 'Healthy adolescents', 'Healthy participants', 'BCG vaccine'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '40334156', 'type': 'DERIVED', 'citation': 'Schmidt AC, Fairlie L, Hellstrom E, Luabeya Kany Kany A, Middelkoop K, Naidoo K, Nair G, Gela A, Nemes E, Scriba TJ, Cinar A, Frahm N, Mogg R, Kaufman D, Dunne MW, Hatherill M; BCG REVAX Study Team. BCG Revaccination for the Prevention of Mycobacterium tuberculosis Infection. N Engl J Med. 2025 May 8;392(18):1789-1800. doi: 10.1056/NEJMoa2412381.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the efficacy of Bacille Calmette Guerin (BCG) revaccination against sustained Mycobacterium tuberculosis infection versus placebo in previously BCG vaccinated QuantiFERON®-TB Gold Plus Assay (QFT) negative, healthy adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant between ≥ 10 years and ≤ 18 years on Study Day 1\n* General good health, confirmed by medical history and physical examination\n* Vaccinated with Bacille Calmette Guerin (BCG) at least 5 years ago, documented through medical history or by presence of healed BCG scar\n* Tests QuantiFERON®-TB Gold Plus Assay (QFT) negative at screening.\n* For female participants: not pregnant and agrees to avoid pregnancy throughout the first 12 months of the study. Women physically capable of pregnancy must agree to use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include sexual abstinence (not engaging in sexual intercourse), a confirmed sterile partner, or at least 2 contraception methods from the following list: male or female condom, diaphragm, intrauterine devices (IUDs), hormonal contraceptive (oral, injection, transdermal patch, or implant).\n* Agrees to stay in contact with the study site for the duration of the study, provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study\n* Capable of giving signed informed consent/assent and completes the written informed consent/assent process.\n\nExclusion Criteria:\n\n* Acute illness on Study Day 1. NOTE: This is a temporary exclusion for which the participant may be re-evaluated\n* Body temperature ≥37.5 degree Celsius on Study Day 1. NOTE: This is a temporary exclusion for which the participant may be re-evaluated\n* History or evidence of any clinically significant disease, including severe eczema and severe asthma, or any acute or chronic illness that might affect the safety, immunogenicity, or efficacy of study vaccine in the opinion of the investigator\n* Any current medical, psychiatric, occupational, or substance abuse problems that, in the opinion of the investigator, will make it unlikely that the participant will comply with the protocol\n* History of autoimmune disease\n* History or evidence of active tuberculosis (TB) disease\n* History or laboratory evidence of any past or present possible immunodeficiency state including, but not limited to, any laboratory indication of human immunodeficiency virus - 1 (HIV-1) infection\n* History of allergic disease that is likely to be exacerbated by any component of the study vaccine\n* History of treatment for active TB disease or history of latent Mycobacterium tuberculosis infection\n* Received a tuberculin skin test within 6 months prior to Study Day 1\n* Received immunosuppressive treatment, e.g., chemotherapy, biologics or radiation therapy, or used immunosuppressive medication (daily steroid equivalent of ≥5 milligrams prednisone) within 42 days before Study Day 1. Inhaled and topical corticosteroids are permitted.\n* Received immunoglobulin or blood products within 42 days before Study Day 1\n* Planned administration/administration of a licensed vaccine in the period starting 28 days before and ending 28 days after Study Day 1\n* Received investigational TB vaccine at any time prior to Study Day 1\n* Received any investigational drug therapy or investigational vaccine within 180 days before Study Day 1, or planned participation in any other clinical trial using investigational product during the study period\n* Laboratory values from the most recent blood collected prior to randomization outside the normal range that are suggestive of a disease state. Grade 1 abnormalities (as per Division of Acquired Immunodeficiency Syndrome toxicity table version 2.1) do not lead to exclusion if the investigator considers them not clinically significant\n* Urinalysis abnormality greater than Grade 1 on the Toxicity Scale (with the exception of hematuria in a menstruating female), or urinalysis abnormality judged clinically significant by the investigator\n* Shared residence with an individual who is receiving TB treatment or with someone who is known to have incompletely treated TB. e.g., Xpert Mycobacterium tuberculosis (MTB)/rifampicin (RIF) assay-positive, polymerase chain reaction-positive, culture-positive, smear-positive TB, or clinically diagnosed unconfirmed TB\n* Child in Care\n* Female participants currently pregnant or lactating/nursing; or positive serum pregnancy test during screening or on Day 1, prior to vaccination, or planning a pregnancy within the first 12 months after study intervention'}, 'identificationModule': {'nctId': 'NCT04152161', 'briefTitle': 'Bacille Calmette Guerin (BCG) Revaccination of Healthy Adolescents for the Prevention of Mycobacterium Tuberculosis Sustained Infection', 'organization': {'class': 'OTHER', 'fullName': 'Gates Medical Research Institute'}, 'officialTitle': 'A Randomized, Placebo Controlled, Observer-Blind, Phase IIb Study to Evaluate the Efficacy, Safety, and Immunogenicity of BCG Revaccination in Healthy Adolescents for the Prevention of Sustained Infection With Mycobacterium Tuberculosis', 'orgStudyIdInfo': {'id': 'Gates MRI-TBV01-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bacille Calmette Guerin (BCG) group', 'interventionNames': ['Biological: BCG vaccine SSI']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'BCG vaccine SSI', 'type': 'BIOLOGICAL', 'description': 'Participants will receive a single 0.1 milliliter (mL) volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.', 'armGroupLabels': ['Bacille Calmette Guerin (BCG) group']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'description': 'Participants will receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7750', 'city': 'Klipfontein', 'state': 'Cape Town', 'country': 'South Africa', 'facility': 'Investigational Site', 'geoPoint': {'lat': -25.81667, 'lon': 28.08333}}, {'zip': '4001', 'city': 'Berea', 'state': 'Durban', 'country': 'South Africa', 'facility': 'Investigational Site', 'geoPoint': {'lat': -29.85185, 'lon': 30.99337}}, {'zip': '2001', 'city': 'Hillbrow', 'state': 'Johannesburg', 'country': 'South Africa', 'facility': 'Investigational Site', 'geoPoint': {'lat': -26.18995, 'lon': 28.04895}}, {'zip': '7626', 'city': 'Paarl', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Investigational Site', 'geoPoint': {'lat': -33.73378, 'lon': 18.97523}}, {'zip': '6850', 'city': 'Worcester', 'state': 'Western Cape', 'country': 'South Africa', 'facility': 'Investigational Site', 'geoPoint': {'lat': -33.64651, 'lon': 19.44852}}], 'overallOfficials': [{'name': 'Gates MRI', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gates Medical Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gates Medical Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}