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NCT01977768 Clinical Trial

TB Immunotherapy Trial With Heat-killed M. Vaccae

Tuberculosis Clinical Trial

— imm03  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01977768
Other study ID # imm03
Secondary ID imm03
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2014
Est. completion date December 2018

Study information
Verified date July 2019
Source Immunitor LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 152
Est. completion date December 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• V7
One pill of V7 once daily for 30 days together with standard of care TB drugs
• Placebo

Locations
Country Name City State
Mongolia Misheel Lung surgery hospital, Ulaanbaatar Ulaanbaatar Region
Ukraine Lisichansk Regional TB Dispensary Lisichansk

Sponsors (5)
Lead Sponsor Collaborator
Immunitor LLC Immunitor USA Inc., Lisichansk Regional Tuberculosis Dispensary, National Medical University, Ukraine, University of Stellenbosch

Countries where clinical trial is conducted

Mongolia,  Ukraine, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Other Immune correlates Identify changes in immune cells (lymphocytes) resulting from V7 administration 2 years
Primary bacillary sputum smear clearance blinded assessment of sputum clearance score two years
Secondary changes in body weight comparison of body weight between treatment arm and placebo 2 years
Secondary changes in body mass index (BMI) comparison of body mass index (BMI) between treatment arm and placebo 2 years
Secondary changes in inflammation markers changes in erythrocyte sedimentation (ERS) rate and leukocyte counts 2 years
Secondary changes in liver function test changes in ALT, AST and total bilirubin levels 2 years
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