Efficacy and Safety of Mycobacterium indicus pranii as an adjunct therapy in Category II pulmonary tuberculosis in a randomized trial

Abstract

Prolonged treatment of tuberculosis (TB) often leads to poor compliance, default and relapse, converting primary TB patients into category II TB (Cat IITB) cases, many of whom may convert to multi-drug resistant TB (MDR-TB). We have evaluated the immunotherapeutic potential of Mycobacterium indicus pranii (MIP) as an adjunct to Anti-Tubercular Treatment (ATT) in Cat II pulmonary TB (PTB) patients in a prospective, randomized, double blind, placebo controlled, multicentric clinical trial. 890 sputum smear positive Cat II PTB patients were randomized to receive either six intra-dermal injections (2 + 4) of heat-killed MIP at a dose of 5 × 108 bacilli or placebo once in 2 weeks for 2 months. Sputum smear and culture examinations were performed at different time points. MIP was safe with no adverse effects. While sputum smear conversion did not show any statistically significant difference, significantly higher number of patients (67.1%) in the MIP group achieved sputum culture conversion at fourth week compared to the placebo (57%) group (p = 0.0002), suggesting a role of MIP in clearance of the bacilli. Since live bacteria are the major contributors for sustained incidence of TB, the potential of MIP in clearance of the bacilli has far reaching implications in controlling the spread of the disease.

Clinical Development of New TB Vaccines: Recent Advances and Next Steps

“…These encouraging data require confirmation in other populations and epidemic settings. A multi-dose regimen of heat-killed M. indicus pranii (MIP), previously known as Mycobacterium w, has also been tested for therapeutic potential among 890 retreatment pulmonary TB patients in a randomized, double-blind, placebo-controlled trial in India (Sharma et al, 2017). MIP vacinees showed a modest increase in the rate of sputum culture conversion from 4 weeks onward compared to placebo (67% vs. 57%), but the rate of relapse TB disease was not significantly different (Sharma et al, 2017).…”

Towards new TB vaccines

“…Mycobacterium indicus pranii (MIP) is a non-pathogenic mycobacterium, FDA approved as a leprosy vaccine [227]. MIP has been shown to be safe in pulmonary TB patients undergoing retreatment for TB [228].…”

Neue Impfstoffe gegen Tuberkulose

“…Ein weiterer Kandidat ist Mycobacterium indicus pranii (MIP; auch unter dem Kürzel Mw geführt). In einer Post-hoc-Analyse von Daten aus einer Leprapräventionsstudie wurde das Auftreten einer TB-Erkrankung in der Studienpopulation ausgewertet [34,47,48]. Die Analyse ergab einen gewissen Schutz gegen TB-Erkrankung.…”