Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
152 participants
INTERVENTIONAL
2014-03-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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V7: Heat-inactivated M. vaccae pill
Daily pill of V7 together with standard tuberculosis therapy
V7
One pill of V7 once daily for 30 days together with standard of care TB drugs
Placebo pill
one pill of placebo pill once per day together with standard of care TB drugs
Placebo
Interventions
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V7
One pill of V7 once daily for 30 days together with standard of care TB drugs
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* sputum smear positive
Exclusion Criteria
* likely to be non-compliant due to drug and/or alcohol abuse
* mentally unfit to comply with treatment
18 Years
80 Years
ALL
No
Sponsors
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National Medical University, Ukraine
OTHER
Immunitor USA Inc.
INDUSTRY
University of Stellenbosch
OTHER
Lisichansk Regional Tuberculosis Dispensary
OTHER
Immunitor LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Aldar Bourinbaiar, PhD, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Immunitor LLC
Locations
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Misheel Lung surgery hospital,
Ulaanbaatar, Ulaanbaatar, Mongolia
Lisichansk Regional TB Dispensary
Lisichansk, , Ukraine
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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imm03
Identifier Type: OTHER
Identifier Source: secondary_id
imm03
Identifier Type: -
Identifier Source: org_study_id
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