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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01977768
Recruitment Status : Completed
First Posted : November 7, 2013
Last Update Posted : July 25, 2019
National Medical University, Ukraine
Immunitor USA Inc.
University of Stellenbosch
Lisichansk Regional Tuberculosis Dispensary
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: V7 Biological: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Phase III and Dose Ranging Trial of Heat-killed M. Vaccae (V7)
Actual Study Start Date : March 2014
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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 Name: 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

Primary Outcome Measures :
  1. bacillary sputum smear clearance [ Time Frame: two years ]
    blinded assessment of sputum clearance score

Secondary Outcome Measures :
  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 Outcome Measures:
  1. Immune correlates [ Time Frame: 2 years ]
    Identify changes in immune cells (lymphocytes) resulting from V7 administration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01977768

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Misheel Lung surgery hospital,
Ulaanbaatar, Ulaanbaatar Region, Mongolia, 21000
Lisichansk Regional TB Dispensary
Lisichansk, Ukraine, 60071
Sponsors and Collaborators
Immunitor LLC
National Medical University, Ukraine
Immunitor USA Inc.
University of Stellenbosch
Lisichansk Regional Tuberculosis Dispensary
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Principal Investigator: Aldar Bourinbaiar, PhD, MD/PhD Immunitor LLC
Study Data/Documents: Clinical Study Report  This link exits the site
Identifier: immunotherapy of TB

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Immunitor LLC Identifier: NCT01977768    
Other Study ID Numbers: imm03
imm03 ( Other Identifier: immunitor )
First Posted: November 7, 2013    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunitor LLC:
M. vaccae
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses