TB Immunotherapy Trial With Heat-killed M. Vaccae

Phase 3

Completed

• Conditions: Tuberculosis
• Interventions: Biological: Placebo; Biological: V7

• Registration Number: NCT01977768
• Lead Sponsor: Immunitor LLC

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

Study Timeline

• Study First Submitted: 2013-10-31
• Study First Submitted QC: 2013-11-06
• Study First Posted: 2013-11-07
• Study Start: 2014-03
• Primary Completion: 2018-10
• Study Completion: 2018-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pill	Placebo	one pill of placebo pill once per day together with standard of care TB drugs
V7: Heat-inactivated M. vaccae pill	V7	Daily pill of V7 together with standard tuberculosis therapy

Primary Outcome Measures

Name	Time	Method
bacillary sputum smear clearance	two years	blinded assessment of sputum clearance score

Secondary Outcome Measures

Name	Time	Method
changes in body weight	2 years	comparison of body weight between treatment arm and placebo
changes in body mass index (BMI)	2 years	comparison of body mass index (BMI) between treatment arm and placebo
changes in inflammation markers	2 years	changes in erythrocyte sedimentation (ERS) rate and leukocyte counts
changes in liver function test	2 years	changes in ALT, AST and total bilirubin levels

Trial Locations

Locations (2)

Misheel Lung surgery hospital,; 🇲🇳 Ulaanbaatar, Ulaanbaatar Region, Mongolia

Lisichansk Regional TB Dispensary; 🇺🇦 Lisichansk, Ukraine