Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-04 @ 12:02 PM
Study NCT ID:
NCT02175420
Status:
COMPLETED
Last Update Posted:
2016-02-23
First Post:
2014-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of BCG as Booster Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001500', 'term': 'BCG Vaccine'}, {'id': 'C057664', 'term': 'Vi polysaccharide vaccine, typhoid'}], 'ancestors': [{'id': 'D032581', 'term': 'Tuberculosis Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-22', 'studyFirstSubmitDate': '2014-06-20', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anti-salmonella typhi Vi antigen antibody titer 2 weeks post TFV', 'timeFrame': '2 weeks', 'description': 'anti-salmonella typhi Vi antigen antibody titers at 2 weeks after TFV will be compared between TFV only and TFV after BCG groups.'}, {'measure': 'anti-salmonella typhi Vi antigen antibody titer 3 months post TFV', 'timeFrame': '3 months', 'description': 'anti-salmonella typhi Vi antigen antibody titers at 3 months after TFV will be compared between TFV only and TFV after BCG groups.'}], 'secondaryOutcomes': [{'measure': 'Change in ex vivo cytokine responses', 'timeFrame': '0, 1 and 4 days; 2 weeks, 3 months', 'description': 'Ex vivo cytokine response to unrelated antigens'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['BCG', 'Salmonella', 'Trained immunity', 'Non-specific effect vaccines'], 'conditions': ['BCG Vaccination']}, 'referencesModule': {'references': [{'pmid': '32065303', 'type': 'DERIVED', 'citation': 'Blok BA, Arts RJW, van Crevel R, Aaby P, Joosten LAB, Benn CS, Netea MG. Differential effects of BCG vaccine on immune responses induced by vi polysaccharide typhoid fever vaccination: an explorative randomized trial. Eur J Clin Microbiol Infect Dis. 2020 Jun;39(6):1177-1184. doi: 10.1007/s10096-020-03813-y. Epub 2020 Feb 17.'}]}, 'descriptionModule': {'briefSummary': "The BCG (bacillus Calmette-Guerin) vaccine is used for the protection against tuberculosis.\n\nApart from it's protective effect against tuberculosis BCG vaccine has been shown to have non-specific effects on the innate immune system and is in epidemiological studies associated with reduced mortality due to infectious diseases.\n\nSeveral studies have shown that BCG can boost the effect of other vaccines. The present study aims to investigate the boosting effect of BCG on the response to typhoid fever vaccine (TFV) and to assess the non-specific effects of BCG on the innate immune system at early timepoints by vaccinating volunteers with either TFV alone or BCG followed by TFV 14 days later.\n\nThe study hypothesis is that when BCG is given 14 days before typhoid fever vaccine a better vaccination result in terms of antibody production will be accomplished against typhoid fever due to the effects of BCG on the innate immune system."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Born in Salmonella typhi endemic country\n* Pregnancy\n* Oral medication except anticonceptive drugs\n* Previous vaccination with BCG and/or TFV'}, 'identificationModule': {'nctId': 'NCT02175420', 'briefTitle': 'Role of BCG as Booster Vaccination', 'organization': {'class': 'OTHER', 'fullName': 'Radboud University Medical Center'}, 'officialTitle': 'Role of BCG Vaccination as Booster on Salmonella Typhi Vaccine', 'orgStudyIdInfo': {'id': 'BCG-TFV1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TFV alone', 'description': 'Typhim Vi', 'interventionNames': ['Biological: TFV']}, {'type': 'EXPERIMENTAL', 'label': 'BCG+TFV', 'description': 'BCG (SSI, Denmark) followed after 14 days by Typhim Vi', 'interventionNames': ['Biological: BCG', 'Biological: TFV']}], 'interventions': [{'name': 'BCG', 'type': 'BIOLOGICAL', 'otherNames': ['BCG vaccine (SSI, Denmark)'], 'armGroupLabels': ['BCG+TFV']}, {'name': 'TFV', 'type': 'BIOLOGICAL', 'otherNames': ['Typhim Vi'], 'armGroupLabels': ['BCG+TFV', 'TFV alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboudumc', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Mihai Netea, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radboud University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radboud University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}