TB Immunotherapy Trial With Heat-killed M. Vaccae (imm03)

July 23, 2019 updated by: Immunitor LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mongolia
    • Ulaanbaatar Region
      • Ulaanbaatar, Ulaanbaatar Region, Mongolia, 21000
        • Misheel Lung surgery hospital,
  • Ukraine
      • Lisichansk, Ukraine, 60071
        • Lisichansk Regional TB Dispensary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: V7: Heat-inactivated M. vaccae pill
Daily pill of V7 together with standard tuberculosis therapy
Biological: V7
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 Comparator: Placebo pill
one pill of placebo pill once per day together with standard of care TB drugs
Biological: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bacillary sputum smear clearance
Time Frame: two years
blinded assessment of sputum clearance score
two years

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunitor LLC

Collaborators

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

Investigators

  • Principal Investigator: Aldar Bourinbaiar, PhD, MD/PhD, Immunitor LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2014

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

November 6, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Actual)

July 25, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imm03 (Other Identifier: immunitor)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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