Tuberculosis (TB) Immunotherapy Phase 2 Study (imm02)

This study has been completed.
Sponsor:
Collaborators:
National Medical University, Ukraine
Immunitor USA Inc.
Information provided by (Responsible Party):
Lisichansk Regional Tuberculosis Dispensary
ClinicalTrials.gov Identifier:
NCT01380119
First received: June 21, 2011
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Tuberculosis
Biological: V7
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Orally Formulated Heat-killed Mycobacterium Vaccae Study in TB Patients

Resource links provided by NLM:


Further study details as provided by Lisichansk Regional Tuberculosis Dispensary:

Primary Outcome Measures:
  • sputum conversion [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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:
  • safety [ Time Frame: 1 and 2 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 40
Study Start Date: August 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380119

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

Publications:

Responsible Party: Lisichansk Regional Tuberculosis Dispensary
ClinicalTrials.gov Identifier: NCT01380119     History of Changes
Other Study ID Numbers: imm02, LisichnskRTD
Study First Received: June 21, 2011
Last Updated: October 25, 2013
Health Authority: Ukraine: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 01, 2014