Clinical trial NCT01977768: TB Immunotherapy Trial With Heat-killed M. Vaccae
Official title: Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tuberculosis
Keywords: M. vaccae
TB
MDR-TB
V7-immunitor
Lead sponsor: Immunitor LLC
Sponsor class: INDUSTRY
Collaborators: name: National Medical University, Ukraine
name: Immunitor USA Inc.
name: University of Stellenbosch
name: Lisichansk Regional Tuberculosis Dispensary
First posted: 2013-11-07
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of TB
* sputum smear positive

Exclusion Criteria:

* pregnant
* likely to be non-compliant due to drug and/or alcohol abuse
* mentally unfit to comply with treatment

Primary outcomes:
measure: bacillary sputum smear clearance
timeFrame: two years
Secondary outcomes:
measure: changes in body weight
timeFrame: 2 years
measure: changes in body mass index (BMI)
timeFrame: 2 years
measure: changes in inflammation markers
timeFrame: 2 years
measure: changes in liver function test
timeFrame: 2 years
Other outcomes:
measure: Immune correlates
timeFrame: 2 years
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Misheel Lung surgery hospital,
state: Ulaanbaatar Region
city: Lisichansk
country: Ukraine
facility: Lisichansk Regional TB Dispensary
Study officials:
affiliation: Immunitor LLC
name: Aldar Bourinbaiar, PhD, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.