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CompletedNCT01977768imm03Updated Jul 25, 2019

TB Immunotherapy Trial With Heat-killed M. Vaccae

A Phase 3 interventional study of V7 and Placebo in Tuberculosis, sponsored by Immunitor LLC. Completed at 2 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-25.

Sponsored by Immunitor LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Tuberculosis

Keywords

  • M. vaccae
  • TB
  • MDR-TB
  • V7-immunitor
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In context

Tuberculosis

1,170 studies on the registry are indexed under Tuberculosis; 175 are open to participants now.

This study's enrollment of 152 is close to the median of 150 across 820 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • confirmed diagnosis of TB
  • sputum smear positive

Exclusion criteria

Exclusion Criteria:

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

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
152 participants (actual)

Study arms

  • Experimental
    V7: Heat-inactivated M. vaccae pill

    Daily pill of V7 together with standard tuberculosis therapy

    Biological: V7

  • Placebo comparator
    Placebo pill

    one pill of placebo pill once per day together with standard of care TB drugs

    Biological: Placebo

Interventions

  • BiologicalV7

    One pill of V7 once daily for 30 days together with standard of care TB drugs

    Also known as: V7 or tableted heat-inactivated mycobacterium vaccae

  • BiologicalPlacebo
06

What researchers measure

Primary outcomes

  1. bacillary sputum smear clearance

    blinded assessment of sputum clearance score

    Time frame: two years

Secondary outcomes

  1. changes in body weight

    comparison of body weight between treatment arm and placebo

    Time frame: 2 years

  2. changes in body mass index (BMI)

    comparison of body mass index (BMI) between treatment arm and placebo

    Time frame: 2 years

  3. changes in inflammation markers

    changes in erythrocyte sedimentation (ERS) rate and leukocyte counts

    Time frame: 2 years

  4. changes in liver function test

    changes in ALT, AST and total bilirubin levels

    Time frame: 2 years

Other outcomes

  1. Immune correlates

    Identify changes in immune cells (lymphocytes) resulting from V7 administration

    Time frame: 2 years

07

Study locations

2 sites
  • Misheel Lung surgery hospital,
    Ulaanbaatar, Ulaanbaatar Region 21000, Mongolia
  • Lisichansk Regional TB Dispensary
    Lisichansk, 60071, Ukraine
08

References and documents

Publications

  • 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. PubMed 24088075 ↗
  • 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. PubMed 23782489 ↗
  • 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. PubMed 22397570 ↗
  • 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. PubMed 30514514 ↗
  • 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. PubMed 31890902 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01977768
Lead sponsor
Immunitor LLC
Collaborators
National Medical University, Ukraine, Immunitor USA Inc., University of Stellenbosch, Lisichansk Regional Tuberculosis Dispensary
Responsible party
Sponsor
First posted
Nov 7, 2013
Start date
Mar 2014
Primary completion
Oct 2018
Completion
Dec 2018
Last update
Jul 25, 2019

Study contacts

Aldar Bourinbaiar, PhD, MD/PhD
principal investigator · Immunitor LLC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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