Tuberculosis (TB) Immunotherapy Phase 2 Study

Phase 2

Completed

• Conditions: Tuberculosis
• Interventions: Biological: V7; Other: placebo

• Registration Number: NCT01380119
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-21
• Study First Submitted QC: 2011-06-22
• Study First Posted: 2011-06-27
• Study Start: 2011-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-25
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
V7	V7	Oral pill containing heat-killed Mycobacterium vaccae
Placebo pill	placebo	Identically appearing placebo pills

Primary Outcome Measures

Name	Time	Method
sputum conversion	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

Name	Time	Method
safety	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.

Trial Locations

Locations (1)

Lisichansk TB Dispensary; 🇺🇦 Lisichansk, Luhansk, Ukraine