NCT01977768

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 25, 2019

Status Verified

July 1, 2019

Enrollment Period

4.6 years

First QC Date

October 31, 2013

Last Update Submit

July 23, 2019

Conditions

Tuberculosis

Keywords

M. vaccaeTBMDR-TBV7-immunitor

Outcome Measures

Primary Outcomes (1)

  • bacillary sputum smear clearance

    blinded assessment of sputum clearance score

    two years

Secondary Outcomes (4)

  • changes in body weight

    2 years

  • changes in body mass index (BMI)

    2 years

  • changes in inflammation markers

    2 years

  • changes in liver function test

    2 years

Other Outcomes (1)

  • Immune correlates

    2 years

Study Arms (2)

V7: Heat-inactivated M. vaccae pill

EXPERIMENTAL

Daily pill of V7 together with standard tuberculosis therapy

Biological: V7

Placebo pill

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

V7BIOLOGICAL

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
V7: Heat-inactivated M. vaccae pill
PlaceboBIOLOGICAL
Placebo pill

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • confirmed diagnosis of TB
  • sputum smear positive

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Misheel Lung surgery hospital,

Ulaanbaatar, Ulaanbaatar, 21000, Mongolia

Location

Lisichansk Regional TB Dispensary

Lisichansk, 60071, Ukraine

Location

Related Publications (5)

  • 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: 24088075BACKGROUND

  • 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: 23782489BACKGROUND

  • 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: 22397570BACKGROUND

  • 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: 30514514RESULT

  • 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.

    PMID: 31890902DERIVED

MeSH Terms

Conditions

TuberculosisTuberculosis, Multidrug-Resistant

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Aldar Bourinbaiar, PhD, MD/PhD

    Immunitor LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 7, 2013

Study Start

March 1, 2014

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

July 25, 2019

Record last verified: 2019-07

Locations

MO(1)UA(1)