Back to results

Tuberculosis (TB) Immunotherapy Phase 2 Study (imm02)

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 2

Locations

Ukraine

Study Type

Interventional

Intervention

placebo

About this trial

This is an interventional treatment trial for Tuberculosis focused on measuring sputum conversion, liver biochemistry, weight loss, quality of life

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
TB score status at baseline.
Agreement to participate in the study and to give a sample of blood for lab testing.
Readily available home or other address where patient can be found.

Exclusion Criteria:

Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Sites / Locations

Lisichansk TB Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Placebo pill

Arm Description

Oral pill containing heat-killed Mycobacterium vaccae

Identically appearing placebo pills

Outcomes

Primary Outcome Measures

sputum conversion

To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:

Secondary Outcome Measures

safety

Liver functions tests (AST and ALT, and bilirubin) as main biochemical tests To confirm quality of life improvement by specially designed questionnaire TB score The beneficial effect on TB-associated wasting by measuring body weight.

Full Information

NCT ID

NCT01380119

First Posted

June 21, 2011

Last Updated

October 25, 2013

Sponsor

Lisichansk Regional Tuberculosis Dispensary

Collaborators

National Medical University, Ukraine, Immunitor USA Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01380119

Brief Title

Tuberculosis (TB) Immunotherapy Phase 2 Study

Acronym

imm02

Official Title

Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Completed

Study Start Date

August 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lisichansk Regional Tuberculosis Dispensary

Collaborators

National Medical University, Ukraine, Immunitor USA Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

6. Conditions and Keywords

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

Tuberculosis

Keywords

sputum conversion, liver biochemistry, weight loss, quality of life

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Oral pill containing heat-killed Mycobacterium vaccae

Arm Title

Placebo pill

Arm Type

Placebo Comparator

Arm Description

Identically appearing placebo pills

Intervention Type

Biological

Intervention Name(s)

Intervention Description

experimental arm

Intervention Type

Other

Intervention Name(s)

placebo

Intervention Description

placebo pill

Primary Outcome Measure Information:

Title

sputum conversion

Description

To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:

Time Frame

2 months

Secondary Outcome Measure Information:

Title

safety

Description

Time Frame

1 and 2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included. TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test. TB score status at baseline. Agreement to participate in the study and to give a sample of blood for lab testing. Readily available home or other address where patient can be found. Exclusion Criteria: Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded. Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry. Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aldar Bourinbaiar, MD/PhD

Organizational Affiliation

Immunitor USA Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Lisichansk TB Dispensary

City

Lisichansk

State/Province

Luhansk

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

21182457

Citation

Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Frolov VM, Tarakanovskaya MG, Batdelger D, Jirathitikal V, Bourinbaiar AS. Adjunct oral immunotherapy in patients with re-treated, multidrug-resistant or HIV-coinfected TB. Immunotherapy. 2011 Feb;3(2):181-91. doi: 10.2217/imt.10.96. Epub 2010 Dec 24.

Results Reference

background

PubMed Identifier

20635986

Citation

Arjanova OV, Prihoda ND, Yurchenko LV, Sokolenko NI, Vihrova LA, Pylypchuk VS, Frolov VM, Kutsyna GA. Enhancement of efficacy of tuberculosis drugs with Immunoxel (Dzherelo) in HIV-infected patients with active pulmonary tuberculosis. Immunotherapy. 2009 Jul;1(4):549-56. doi: 10.2217/imt.09.25.

Results Reference

background

PubMed Identifier

21244690

Citation

Butov DA, Pashkov YN, Stepanenko AL, Choporova AI, Butova TS, Batdelger D, Jirathitikal V, Bourinbaiar AS, Zaitzeva SI. Phase IIb randomized trial of adjunct immunotherapy in patients with first-diagnosed tuberculosis, relapsed and multi-drug-resistant (MDR) TB. J Immune Based Ther Vaccines. 2011 Jan 18;9:3. doi: 10.1186/1476-8518-9-3.

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

result

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

result

Learn more about this trial

Tuberculosis (TB) Immunotherapy Phase 2 Study

We'll reach out to this number within 24 hrs