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Completed

NCT Number: NCT01977768

TB Immunotherapy Trial With Heat-killed M. Vaccae

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.

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Key information

Conditions

Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis, Multidrug-Resistant

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Misheel Lung surgery hospital,, Ulaanbaatar, Mongolia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V7

Biological

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

Other names: V7 or tableted heat-inactivated mycobacterium vaccae

Placebo

Biological

Primary outcomes

  1. bacillary sputum smear clearance

    Time frame: two years

    blinded assessment of sputum clearance score

Secondary outcomes

  1. changes in body weight

    Time frame: 2 years

    comparison of body weight between treatment arm and placebo

  2. changes in body mass index (BMI)

    Time frame: 2 years

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

  3. changes in inflammation markers

    Time frame: 2 years

    changes in erythrocyte sedimentation (ERS) rate and leukocyte counts

  4. changes in liver function test

    Time frame: 2 years

    changes in ALT, AST and total bilirubin levels

Other outcomes

  1. Immune correlates

    Time frame: 2 years

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

Sponsors and collaborators

Lead sponsor

Immunitor LLC

Industry

Collaborators

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

Registry information

Official study title

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

Acronym: imm03

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2013
Registry last updated
Jul 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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