Tuberculosis (TB) remains as one of the most serious public health problems worldwide. It is one of the main
causes of death in poor and developing countries, especially in sub-Saharan Africa, where it may be associated with the
human immunodeficiency virus (HIV). It has been estimated that one third of the world population is infected by Mycobacterium
tuberculosis (Mtb), and there were about 8.7 million new TB cases, and about 1.4 million yearly deaths due to
TB in 2011. DOTS is the currently used drug therapy in TB but there is non-compliance which results in emergence of resistance.
Bacille Calmette Guérin (BCG), an attenuated vaccine derived from Mycobacterium bovis, is the only licensed
TB vaccine, but not recommended in HIV-infected infants. There are 14 vaccine candidates that have entered clinical trials
and over 35 candidates in discovery and preclinical development. Mycobacterium indicus pranii [Mw; MIP] and
M. vaccae are in phase III clinical trial and the Drug Controller of India licensed MIP for human use in India.
Keywords: Clinical trials, review, tuberculosis, tuberculosis vaccines.
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