This study reports detailed analysis of clinical parameters and clearance of
granuloma in
borderline leprosy patients treated with
immunotherapy and
chemotherapy. It aims to assess the additive effect of
immunotherapy (Mwvaccine) with standard MDT on clinical status of untreated
borderline leprosy cases and on
granuloma fraction of untreated
borderline leprosy cases. Patients attending the OPD were serially recruited in two groups. A total of 150 cases in one treatment (trial) group (
Mw vaccine plus MDT) and 120 cases in another treatment (control) group (MDT only) of border line
leprosy have been included. After the formal written consent, detailed clinical examination, charting, smear examination of all untreated borderline patients of both groups was done, biopsies were taken from the active lesions of all patients of both groups at start of
therapy and every six month thereafter till the completion of
therapy. The same procedure was repeated every six months during the follow-up period. Standard MDT was given to all the patients of both groups according to type of disease.
Mw vaccine 0.1 ml (0.5 x 10(9) bacilli) was injected intra-dermally at the start of
therapy and every six months in addition to
chemotherapy to the treatment group. The BT cases were followed up after 6 doses of MDT and 2 doses of
Mw vaccine, and, the BB, BL cases were followed up after 24 doses of MDT plus 5 doses of
Mw vaccine. Clinically, greater and faster improvement was observed in all the clinical parameters, faster attainment of smear negativity and two episodes of lepra reaction occurred in cases treated with combined
chemotherapy and
immunotherapy, as compared to controls (
chemotherapy alone) wherein clinical improvement was slower in all parameters, slower attainment of smear negativity in bacillary index and seven showed the occurrence of reactions, histipathologically in addition to more rapid clearance of
granuloma in
immunotherapy treated group, a significant finding was an increase in the epithelioid cells population in this group. This suggests a possible immunoactivation of the macrophages especially in BB/BL
immunotherapy group. Overall comparison of regression induced by
chemotherapy alone with that induced by combined
chemotherapy and
immunotherapy shows a greater reduction in clinical parameters as well as
granuloma fraction in BT cases as well as in BB/BL cases. This trial shows the potential usefulness of this approach of addition of
immunotherapy to standard
chemotherapy in
borderline leprosy cases which leads to in faster recovery from disease reduced chances of reactions and faster
granuloma clearance. Such information is expected to be useful in improving the immunotherapeutic approaches for treatinggranulomatous conditions in general and in
leprosy in particular.