Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-10 @ 1:54 AM
Study NCT ID:
NCT00241657
Status:
COMPLETED
Last Update Posted:
2005-12-15
First Post:
2005-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Responses to BCG Vaccination in Malawi and the UK
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2002-12', 'lastUpdateSubmitDate': '2005-12-14', 'studyFirstSubmitDate': '2005-10-17', 'studyFirstSubmitQcDate': '2005-10-18', 'lastUpdatePostDateStruct': {'date': '2005-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delayed-type hypersensitivity'}, {'measure': 'cytokine responses (eg IFNg) to mycobacterial antigens'}], 'secondaryOutcomes': [{'measure': 'scar size'}]}, 'conditionsModule': {'conditions': ['Immunity, Cellular', 'Hypersensitivity, Delayed Type']}, 'descriptionModule': {'briefSummary': 'BCG vaccination has been found to provide greater protection against TB in the UK than in Malawi. This study compares immune responses in BCG-vaccinated and unvaccinated teenagers and young adults in Malawi and in the UK.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BCG unvaccinated\n* HIV negative\n* Not pregnant\n* Informed Consent\n\nExclusion Criteria:\n\n* HIV positive\n* Pregnant\n* Seriously ill'}, 'identificationModule': {'nctId': 'NCT00241657', 'briefTitle': 'Immune Responses to BCG Vaccination in Malawi and the UK', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'orgStudyIdInfo': {'id': 'KPS10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'BCG', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'PO Box 36', 'city': 'Chilumba', 'state': 'Karonga District', 'country': 'Malawi', 'facility': 'Karonga Prevention Study', 'geoPoint': {'lat': -10.43344, 'lon': 34.24773}}, {'zip': 'IG1 2QX', 'city': 'Ilford', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'Redbridge and Waltham Forest Primary Care Trust', 'geoPoint': {'lat': 51.55765, 'lon': 0.07278}}], 'overallOfficials': [{'name': 'Paul EM Fine, VMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}}}}