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.