Author

Intervention

No. of Cases, &Controls included

 Result

Zaheer, et al. (1991) [56] (Case report)

Four doses of M. w administered to lepromatous leprosy (LL) patient

1

After 15 months of treatment, this patient attained bacteriological negativity and clinical inactivity. Histo-pathologically the patient upgraded to borderline-tuberculoid at 12 months, and at 15 months showed features of nonspecific infiltration in the dermis. The rapid immunological upgrading is seen in the patient.

Mukherjee, et al. (1992) [57]

Mw is used in conjunction with a standard chemotherapeutic regimen in MB patients.

122 (vaccine group-87, control group-35)

The histopathological profile of the initial 87 patients in the vaccine group, 35 in the control group) have been observed. The vaccine group received multidrug therapy (MDT) and eight intradermal injections of M. w. every 3 months; the control group had MDT with starch injections as a placebo. The results show a significantly higher proportion of biopsies with histopathological upgrading and/or clearance of dermal granuloma among the vaccinated cases. The number of patients becoming bacteriologically negative was higher in the vaccine group.

Zaheer, et al. (1993) [58]

Combined immunotherapy with Mycobacterium vaccine with a standard multidrug regimen given MB leprosy patients

 Total 81 (LL patient vaccine group-17, control-15), BL (14 vaccine, 10 control group), BB (14 Vaccine, 11 control)

Clinical improvement in the group given the vaccine was shown by a more rapid fall in Ramu's clinical score in association with flattening and regression of lesions in contrast to the group receiving multidrug therapy alone. At 12, 18, and 24 months, the fall in clinical scores was statistically significant in BB and LL vaccine group patients but not in control patients (P < 0.01). In BL leprosy it was significant at 18 and 24 months (P < 0.01).

Kar, et al. (1993) [59]

Mw was given in addition to standard MDT to M B lepromin negative patients belonging to BB, BL, and LL types of leprosy (vaccine group).

106 (53 vaccine group). An equal control group received MDT and injections of placebo)

The incidence of reversal reaction (RR) was marginally higher in the vaccine group (22.6% vaccine group vs. 15% control group).

Sharma, et al. (2000) [60]

Mw in addition to standard MDT, given to bacteriologically positive, lepromin negative MB leprosy patients compared the control group who received a placebo injection in addition to MDT

300 (156 vaccine group, 145 control group who received a placebo injection in addition to MDT

The fall in clinical scores and bacteriological indices was significantly more rapid in vaccinated patients, from 6 months onward until years 2 or 3 of therapy. However, no difference was observed in the fall in bacteriological index in the two groups from year 4 onwards

Sarkar, et al. (2001) [61]

Four doses of Mw given to MB patients along with standard therapy

40 (20 in study group MDT + Mw, 20 control group MDT only)

A patient receiving Mw + MDT shows significant improvements in histopathological, immunological parameters in comparison to the control group receiving only MDT. The incidence of type 1 reaction was more in the Mw + MDT group (30% vs. 10%), while the incidence of type 2 reaction was more in the Control group (25% vs. 15%). 

Katoch, et al. (2004) [62]

Mw is given to untreated BL/LL patients with high BI cases, along with standard MDT. One of the three treatment groups was assigned. the control group received distilled water, another group received BCG, and another group received M. w every 6 months

36 BL/LL patient (12 patient in Group I receiving WHO MDT + BCG, Group II patients received MDT and Mw, Group III Control patients received MDT with 0.1 ml of distilled water

Histologically patients in both the immunotherapy groups (groups I and II) showed accelerated granuloma clearance, histological upgrading, and non-specific healing

Narang, et al. (2005) [63]

Standard MDT has given to Untreated MB patients in two comparison groups Mw + MDT, BCG + MDT

60 (20 in Group A M.D.T. + BCG intradermally, 20 in Group B M.D.T. + Mw, 20 in Group C M.D.T. + normal saline as placebo. 

BCG exhibited a slightly better and faster effect on bacteriological clearance and clinical improvement as compared to the Mw vaccine in borderline lepromatous (BL)/polar lepromatous (LL) patients with a high initial B.I., however, their effect on histo-pathological (decrease in granuloma formations) improvement was comparable.

Kamal, et al. (2012) [64]

Mw is given to untreated borderline leprosy patients in Non-randomized fashion along with standard MDT

270 (150 cases in one treatment (trial) group (Mw vaccine plus MDT) and 120 cases in another treatment (control) group (MDT only)

Faster clinical recovery from disease and histopathological faster granuloma and bacillary clearance and lesser incidences of reactions were observed in an Mw + MDT group in comparison to MDT only

Kamal, et al. (2017) [65]

Double-blind placebo-controlled study: MIP vaccine added to standard MDT regimen in patients with borderline tuberculoid leprosy

90 (46 patients (13 BT, 11 BB, 22 BL) were in group 1 (intervention, MDT + MIP) and 44 patients (23 BT, 13 BB, eight BL) were in group 2 (control, MDT + placebo)

The preliminary result shows faster bacillary clearance and clinical recovery Early (initial 6 months) occurrence of Type 1 and 2 lepra reactions when compared with the control group due to the immunomodulatory effect of the vaccine. Later (6-12 months and beyond) incidence of reactions was found to be lower indicating reduced morbidity due to reactions in the vaccinated group