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TB Immunotherapy Trial With Heat-killed M. Vaccae (imm03)

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring M. vaccae, TB, MDR-TB, V7-immunitor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Misheel Lung surgery hospital,
Lisichansk Regional TB Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

V7: Heat-inactivated M. vaccae pill

Placebo pill

Arm Description

Daily pill of V7 together with standard tuberculosis therapy

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

Outcomes

Primary Outcome Measures

bacillary sputum smear clearance

blinded assessment of sputum clearance score

Secondary Outcome Measures

changes in body weight

comparison of body weight between treatment arm and placebo

changes in body mass index (BMI)

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

changes in inflammation markers

changes in erythrocyte sedimentation (ERS) rate and leukocyte counts

changes in liver function test

changes in ALT, AST and total bilirubin levels

Full Information

NCT ID

NCT01977768

First Posted

October 31, 2013

Last Updated

July 23, 2019

Sponsor

Immunitor LLC

Collaborators

National Medical University, Ukraine, Immunitor USA Inc., University of Stellenbosch, Lisichansk Regional Tuberculosis Dispensary

1. Study Identification

Unique Protocol Identification Number

NCT01977768

Brief Title

TB Immunotherapy Trial With Heat-killed M. Vaccae

Acronym

imm03

Official Title

Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Immunitor LLC

Collaborators

National Medical University, Ukraine, Immunitor USA Inc., University of Stellenbosch, Lisichansk Regional Tuberculosis Dispensary

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

M. vaccae, TB, MDR-TB, V7-immunitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V7: Heat-inactivated M. vaccae pill

Arm Type

Experimental

Arm Description

Daily pill of V7 together with standard tuberculosis therapy

Arm Title

Placebo pill

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

Other Intervention Name(s)

V7 or tableted heat-inactivated mycobacterium vaccae

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

bacillary sputum smear clearance

Description

blinded assessment of sputum clearance score

Time Frame

two years

Secondary Outcome Measure Information:

Title

changes in body weight

Description

comparison of body weight between treatment arm and placebo

Time Frame

2 years

Title

changes in body mass index (BMI)

Description

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

Time Frame

2 years

Title

changes in inflammation markers

Description

changes in erythrocyte sedimentation (ERS) rate and leukocyte counts

Time Frame

2 years

Title

changes in liver function test

Description

changes in ALT, AST and total bilirubin levels

Time Frame

2 years

Other Pre-specified Outcome Measures:

Title

Immune correlates

Description

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

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aldar Bourinbaiar, PhD, MD/PhD

Organizational Affiliation

Immunitor LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Misheel Lung surgery hospital,

City

Ulaanbaatar

State/Province

Ulaanbaatar Region

ZIP/Postal Code

21000

Country

Mongolia

Facility Name

Lisichansk Regional TB Dispensary

City

Lisichansk

ZIP/Postal Code

60071

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

24088075

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.

Results Reference

background

PubMed Identifier

23782489

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.

Results Reference

background

PubMed Identifier

22397570

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.

Results Reference

background

PubMed Identifier

30514514

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.

Results Reference

result

PubMed Identifier

31890902

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.

Results Reference

derived

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TB Immunotherapy Trial With Heat-killed M. Vaccae

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