Tuberculosis (TB) Immunotherapy Phase 2 Study (imm02)

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: NCT01380119
Recruitment Status : Completed
First Posted : June 27, 2011
Last Update Posted : October 29, 2013
National Medical University, Ukraine
Immunitor USA Inc.
Information provided by (Responsible Party):
Lisichansk Regional Tuberculosis Dispensary

Brief Summary:
This is a phase II, randomized, placebo-controlled trial, aimed to seek the therapeutic benefit of V7 in combination with standard of care anti-Tuberculosis (TB) therapy (ATT) among Mycobacterium tuberculosis-infected sputum smear positive subjects. The results will be compared to placebo combined with standard ATT therapy. The trial will consist of one stage with sputum evaluation at months 1 and 2.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: V7 Other: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Arm Intervention/treatment
Experimental: V7
Oral pill containing heat-killed Mycobacterium vaccae
Biological: V7
experimental arm
Placebo Comparator: Placebo pill
Identically appearing placebo pills
Other: placebo
placebo pill

Primary Outcome Measures :
  1. sputum conversion [ Time Frame: 2 months ]
    To compare the efficacy of combination of V7 with anti-TB treatment versus anti-TB treatment+placebo in adults with pulmonary tuberculosis including:

Secondary Outcome Measures :
  1. safety [ Time Frame: 1 and 2 months ]
    1. Liver functions tests (AST and ALT, and bilirubin) as main biochemical tests
    2. To confirm quality of life improvement by specially designed questionnaire TB score
    3. The beneficial effect on TB-associated wasting by measuring body weight.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects who are at least 18 years old and are willing and capable of providing informed consent. Both men and non-pregnant women will be included.
  • TB infection documented prior to Study Entry by sputum smear positive for acid-fast bacilli (AFB) test.
  • TB score status at baseline.
  • Agreement to participate in the study and to give a sample of blood for lab testing.
  • Readily available home or other address where patient can be found.

Exclusion Criteria:

  • Subjects who might have already taken V5 in prior trial and have no baseline data. Pregnant or breast-feeding women are excluded.
  • Subjects who have taken study unrelated drugs or immunomodulatory therapies during study or prior to Entry.
  • Medical conditions such as active alcohol or substance abuse, or psychological issues that in the opinion of the local investigator would interfere with adherence to the requirements of this study.

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): NCT01380119

Lisichansk TB Dispensary
Lisichansk, Luhansk, Ukraine
Sponsors and Collaborators
Lisichansk Regional Tuberculosis Dispensary
National Medical University, Ukraine
Immunitor USA Inc.
Study Director: Aldar Bourinbaiar, MD/PhD Immunitor USA Inc.

Publications of Results:
Other Publications:
Responsible Party: Lisichansk Regional Tuberculosis Dispensary Identifier: NCT01380119     History of Changes
Other Study ID Numbers: imm02
LisichnskRTD ( Other Identifier: LisichanskRTD )
First Posted: June 27, 2011    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by Lisichansk Regional Tuberculosis Dispensary:
sputum conversion
liver biochemistry
weight loss
quality of life

Additional relevant MeSH terms:
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections