Tuberculosis (TB) Immunotherapy Phase 2 Study (imm02)

October 25, 2013 updated by: Lisichansk Regional Tuberculosis Dispensary

Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

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

  • Ukraine
    • Luhansk
      • Lisichansk, Luhansk, Ukraine
        • Lisichansk 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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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:
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 and 2 months

Collaborators and Investigators

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

Sponsor

Lisichansk Regional Tuberculosis Dispensary

Collaborators

National Medical University, Ukraine
Immunitor USA Inc.

Investigators

  • Study Director: Aldar Bourinbaiar, MD/PhD, Immunitor USA Inc.

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

August 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

June 21, 2011

First Submitted That Met QC Criteria

June 22, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 25, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • imm02
  • LisichnskRTD (OTHER: LisichanskRTD)

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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