02279nas a2200265 4500000000100000008004100001653001300042653001900055653001200074653002400086653001700110653002200127100001400149700001400163700001400177700001300191700001500204700001100219245022300230856005100453300001000504490000700514050001600521520147600537 2013 d10aReaction10aNerve function10aleprosy10aClinical regression10aChemotherapy10aBCG immunotherapy1 aShetty VP1 aMistry NF1 aWakade AV1 aGhate SD1 aCapadia GD1 aPai VV00aBCG immunotherapy as an adjunct to chemotherapy in BL-LL patients – its effect on clinical regression, reaction severity, nerve function, lepromin conversion, bacterial/antigen clearance and ‘persister’ M. leprae uhttps://leprosyreview.org/article/84/1/02-3040 a23-400 v84 aSHETTY 20133 a

Summary Background and Objective: Multidrug therapy in leprosy has failed to eliminate the problem of persister bacilli. Clearance of bacterial antigens is extremely slow which could predispose to continued nerve damage even after release from treatment. In the present study the immunomodulatory efficacy of BCG vaccine administered post-MDT in BL-LL leprosy patients was investigated in depth with a view to determining if augmenting chemotherapy with immunotherapy would help in faster clearance of M. leprae/antigens, bring down the level of persisters and minimise the occurrence/severity of reaction and nerve damage. Methods: This is a placebo-controlled study in treated BL-LL patients. The patients are matched with respect to age, sex, bacteriological index and history of reaction, stratified and allocated to the two groups. One group (Gr A) received two doses of BCG-MOSCOW (3-33x105 cells) and the other (Gr B) normal saline (0·85%), injected intra-dermally at 3 month intervals. The Primary outcomes assessed at the end of 6 months were bacterial/antigen clearance, lepromin conversion, granuloma clearance and the occurrence of persisters. The secondary outcomes were clinical regression, occurrence and severity of reaction and changes in nerve functions. Material: A total of 107 BL-LL patients comprised of 49 in Gr A and 58 in Gr B; of which 36 and 42 respectively completed the study as per protocol, and are included in the final analysis.