TB Immunotherapy Trial With Heat-killed M. Vaccae

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01977768

Acronym

imm03

Enrollment

152

Registered

2013-11-07

Start date

2014-03-31

Completion date

2018-12-31

Last updated

2019-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis

Keywords

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

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

Interventions

BIOLOGICALV7

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

BIOLOGICALPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
bacillary sputum smear clearance	two years	blinded assessment of sputum clearance score

Secondary

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Immune correlates	2 years	Identify changes in immune cells (lymphocytes) resulting from V7 administration

Countries

Mongolia, Ukraine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026