Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-21 @ 12:06 PM
Study NCT ID:
NCT01977768
Status:
COMPLETED
Last Update Posted:
2019-07-25
First Post:
2013-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TB Immunotherapy Trial With Heat-killed M. Vaccae
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D018088', 'term': 'Tuberculosis, Multidrug-Resistant'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-23', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-06', 'lastUpdatePostDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Immune correlates', 'timeFrame': '2 years', 'description': 'Identify changes in immune cells (lymphocytes) resulting from V7 administration'}], 'primaryOutcomes': [{'measure': 'bacillary sputum smear clearance', 'timeFrame': 'two years', 'description': 'blinded assessment of sputum clearance score'}], 'secondaryOutcomes': [{'measure': 'changes in body weight', 'timeFrame': '2 years', 'description': 'comparison of body weight between treatment arm and placebo'}, {'measure': 'changes in body mass index (BMI)', 'timeFrame': '2 years', 'description': 'comparison of body mass index (BMI) between treatment arm and placebo'}, {'measure': 'changes in inflammation markers', 'timeFrame': '2 years', 'description': 'changes in erythrocyte sedimentation (ERS) rate and leukocyte counts'}, {'measure': 'changes in liver function test', 'timeFrame': '2 years', 'description': 'changes in ALT, AST and total bilirubin levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['M. vaccae', 'TB', 'MDR-TB', 'V7-immunitor'], 'conditions': ['Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '24088075', 'type': 'BACKGROUND', 'citation': 'Butov DA, Efremenko YV, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled Phase II trial of heat-killed Mycobacterium vaccae (Immodulon batch) formulated as an oral pill (V7). Immunotherapy. 2013 Oct;5(10):1047-54. doi: 10.2217/imt.13.110.'}, {'pmid': '23782489', 'type': 'BACKGROUND', 'citation': 'Efremenko YV, Butov DA, Prihoda ND, Zaitzeva SI, Yurchenko LV, Sokolenko NI, Butova TS, Stepanenko AL, Kutsyna GA, Jirathitikal V, Bourinbaiar AS. Randomized, placebo-controlled phase II trial of heat-killed Mycobacterium vaccae (Longcom batch) formulated as an oral pill (V7). Hum Vaccin Immunother. 2013 Sep;9(9):1852-6. doi: 10.4161/hv.25280. Epub 2013 Jun 19.'}, {'pmid': '22397570', 'type': 'BACKGROUND', 'citation': 'Bourinbaiar AS, Mezentseva MV, Butov DA, Nyasulu PS, Efremenko YV, Jirathitikal V, Mishchenko VV, Kutsyna GA. Immune approaches in tuberculosis therapy: a brief overview. Expert Rev Anti Infect Ther. 2012 Mar;10(3):381-9. doi: 10.1586/eri.12.1.'}, {'pmid': '30514514', 'type': 'RESULT', 'citation': 'Atmakuri K, Penn-Nicholson A, Tanner R, Dockrell HM. Meeting report: 5th Global Forum on TB Vaccines, 20-23 February 2018, New Delhi India. Tuberculosis (Edinb). 2018 Dec;113:55-64. doi: 10.1016/j.tube.2018.08.013. Epub 2018 Aug 24.'}, {'pmid': '31890902', 'type': 'DERIVED', 'citation': 'Bourinbaiar AS, Batbold U, Efremenko Y, Sanjagdorj M, Butov D, Damdinpurev N, Grinishina E, Mijiddorj O, Kovolev M, Baasanjav K, Butova T, Prihoda N, Batbold O, Yurchenko L, Tseveendorj A, Arzhanova O, Chunt E, Stepanenko H, Sokolenko N, Makeeva N, Tarakanovskaya M, Borisova V, Reid A, Kalashnikov V, Nyasulu P, Prabowo SA, Jirathitikal V, Bain AI, Stanford C, Stanford J. Phase III, placebo-controlled, randomized, double-blind trial of tableted, therapeutic TB vaccine (V7) containing heat-killed M. vaccae administered daily for one month. J Clin Tuberc Other Mycobact Dis. 2019 Dec 12;18:100141. doi: 10.1016/j.jctube.2019.100141. eCollection 2020 Feb.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to carry out multi-country (Ukraine and Mongolia), placebo-controlled, randomized Phase III trial in patients with drug-sensitive, multi-drug resistant (MDR-TB) and TB-HIV and identify efficacy and safety of whole-cell, heat-killed Mycobacterium vaccae formulated as a pill (V7) and consequently conduct confirmatory trials in intended registration countries, such as China, Russia and South Africa, etc.', 'detailedDescription': 'Main end-point is negative sputum conversion rate after one month in patients on V7 vs placebo arm, both arms will receive conventional anti-tuberculosis chemotherapy consisting of 1st and/or 2nd line TB drugs according to baseline diagnosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed diagnosis of TB\n* sputum smear positive\n\nExclusion Criteria:\n\n* pregnant\n* likely to be non-compliant due to drug and/or alcohol abuse\n* mentally unfit to comply with treatment'}, 'identificationModule': {'nctId': 'NCT01977768', 'acronym': 'imm03', 'briefTitle': 'TB Immunotherapy Trial With Heat-killed M. Vaccae', 'organization': {'class': 'INDUSTRY', 'fullName': 'Immunitor LLC'}, 'officialTitle': 'Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)', 'orgStudyIdInfo': {'id': 'imm03'}, 'secondaryIdInfos': [{'id': 'imm03', 'type': 'OTHER', 'domain': 'immunitor'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V7: Heat-inactivated M. vaccae pill', 'description': 'Daily pill of V7 together with standard tuberculosis therapy', 'interventionNames': ['Biological: V7']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo pill', 'description': 'one pill of placebo pill once per day together with standard of care TB drugs', 'interventionNames': ['Biological: Placebo']}], 'interventions': [{'name': 'V7', 'type': 'BIOLOGICAL', 'otherNames': ['V7 or tableted heat-inactivated mycobacterium vaccae'], 'description': 'One pill of V7 once daily for 30 days together with standard of care TB drugs', 'armGroupLabels': ['V7: Heat-inactivated M. vaccae pill']}, {'name': 'Placebo', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Placebo pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Ulaanbaatar', 'state': 'Ulaanbaatar', 'country': 'Mongolia', 'facility': 'Misheel Lung surgery hospital,', 'geoPoint': {'lat': 47.90771, 'lon': 106.88324}}, {'zip': '60071', 'city': 'Lisichansk', 'country': 'Ukraine', 'facility': 'Lisichansk Regional TB Dispensary', 'geoPoint': {'lat': 48.90421, 'lon': 38.44094}}], 'overallOfficials': [{'name': 'Aldar Bourinbaiar, PhD, MD/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Immunitor LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Immunitor LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Medical University, Ukraine', 'class': 'OTHER'}, {'name': 'Immunitor USA Inc.', 'class': 'INDUSTRY'}, {'name': 'University of Stellenbosch', 'class': 'OTHER'}, {'name': 'Lisichansk Regional Tuberculosis Dispensary', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}