Tuberculosis (TB) Immunotherapy Phase 2 Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Tuberculosis

Intervention / Treatment
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* Biological: V7
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: V7<br>Oral pill containing heat-killed Mycobacterium vaccae | Biological: V7<br>* experimental arm<br>|
| Placebo Comparator: Placebo pill<br>Identically appearing placebo pills | Other: placebo<br>* placebo pill<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sputum conversion | 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 | Liver functions tests (AST and ALT, and bilirubin) as main biochemical tests To confirm quality of life improvement by specially designed questionnaire TB score The beneficial effect on TB-associated wasting by measuring body weight. | 1 and 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sputum conversion, liver biochemistry, weight loss, quality of life