Sa. Zaheer et al., ADDITION OF IMMUNOTHERAPY WITH MYCOBACTERIUM-W VACCINE TO MULTIDRUG THERAPY BENEFITS MULTIBACILLARY LEPROSY PATIENTS, Vaccine, 13(12), 1995, pp. 1102-1110
Immunotherapy with a vaccine consisting of autoclaved Mycobacterium w,
was given in addition to standard chemotherapy (multidrug therapy (MD
T)) to 93 multibacillary (MB) leprosy patients. One hundred and seven
patients with similar types of disease served as controls and received
MDT + placebo injections, The study was a double-blind randomised tri
al. On opening the codes, results obtained were in concordance with th
ose in a single-blind trial which has been extensively reported Bacter
iological clearances were significantly more rapid in vaccinated patie
nts (p<0.03). Thirty-Jive LL or BL patients with a high bacterial inde
x (BI) of 6 were completely cleared of acid-fast bacilli (AFB) after e
ight doses of vaccine. Only 8 patients in the control group became bac
teriologically negative in the same time period. They all had BIs <4.
Associated with decreasing BI was accelerated clinical regression of l
esions after vaccination and lepromin conversion rates of 100% for BB,
71% for BL and 70% for LL. A significant number of immunised patients
showed histological improvement (p<0.004). Thirty-six showed a comple
te disappearance of dermal granulomas and a picture of non-specific in
filtration. The vaccine did not precipitate pleuritis or deformities;
episodes were noted in vaccinated patients as were incidences of Type
2 reaction, The overall improvement was reflected by a shorter duratio
n of treatment and faster release of vaccinated patients.