A
vaccine based on autoclaved Mycobacterium w was administered, in addition to standard multidrug
therapy (MDT), to 157 bacteriologically positive,
lepromin-negative,
multibacillary leprosy patients supported by a well-matched control group of 147 patients with similar type of disease who received a placebo injection in addition to MDT. The MDT was given for a minimum period of 2 years and continued until skin-smear negativity, while the
vaccine/placebo was given at 3-month intervals up to a maximum of 8 doses in the initial 2 years. The overall incidence of type 1 and type 2 reactions and
neuritis during treatment and follow up was nearly equal in the patients in the
vaccine and placebo groups; the differences were not statistically significant. The occurrence of disabilities, such as
anesthesia, trophic
ulcers, claw hand and grade 3
deformities, were not different statistically in the
vaccine and placebo groups, an observation valid both for
deformities present at induction and for those which developed during the course of
therapy and surveillance. A statistically significant difference was observed in the recovery of newly developed trophic
ulcers; recovery was quicker in the
vaccine group. The recovery rate for motor
deformities was marginally higher in the
vaccine group, although not significant (p = 0.068) statistically. There was a statistically significant reduction in the incidence of grade 3
deformities following MDT with and without
immunotherapy. To conclude, the addition of
vaccine to MDT did not precipitate
neuritis or
deformities over and above that encountered with MDT alone, although it did accelerate bacteriological clearance, histopathological upgrading, conversion to
lepromin positivity, and clinical improvement.