Effect of immunotherapy as an adjunct to chemotherapy on the M.lepre persisters and peripheral nerve functions
Principal Investigator Dr. Vanaja P Shetty
Collaborators Bombay Leprosy Project (Dr. VV Pai)
Project team Dr. Nerges F Mistry (Co PI), Dr. Sunil Ghate, Ms. Anju Dighe, Ms. Gospi Capadia (FMR)
Funder Tata Education Trust, Mumbai
Duration March 2003 – April 2007
Budget Rs. 37.50 Lakhs
To examine the effect of BCG vaccine given as an immunomodulator on borderline lepromatous (BL) and lepromatous (LL) MB patients who have completed a full course of treatment.
We compared the clinical characteristics, bacteriological index, histopathological characteristics, antigen clearance, lepromin conversion and level of persisters, of MB leprosy patients who had completed multidrug therapy for leprosy and were administered BCG vaccine with a comparable group which was administered placebo.
The study findings show that 2 doses of BCG given post MDT did not make any significant impact on clinical regression of lesions, bacterial clearance, granuloma clearance, and lepromin conversion (Shetty et al., 2013). Most importantly use of BCG as an immunomodulator did not alter the level of persisters in this study group of patients. Occurrence of reaction (T2R) was higher in the BCG arm. Among the patients developing reaction majority had past history of reaction and it was also noted that addition of BCG increased the risk of reaction by 2 fold. Despite of a higher incidence of reaction, there was no adverse effect on the motor nerve function impairments in the BCG arm. Since all the patients developing reaction received corticosteroids, further subgroup analysis is needed to discern the effect of steroid over BCG.