Tuberculosis (TB) Immunotherapy Phase 2 Study
Tuberculosis (TB) Immunotherapy Phase 2 Study
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.
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.