S. Chaudhury et al., AN 8-YEAR FIELD TRIAL ON ANTILEPROSY VACCINES AMONG HIGH-RISK HOUSEHOLD CONTACTS IN THE CALCUTTA METROPOLIS, International journal of leprosy and other mycobacterial diseases, 62(3), 1994, pp. 389-394
One-hundred-seventy-nine lepromin-negative household contacts were vac
cinated with heat-killed Mycobacterium leprae, BCG, or a combination o
f the two. Vaccination induced lepromin positivity in 131 of these con
tacts. Over an 8-year follow-up period, 12 lepromin-positive contacts
developed leprosy, all tuberculoid; while 2 lepromin-negative vaccinat
ed contacts developed leprosy, both lepromatous. Overall, 7.8% of the
vaccinated contacts developed the disease. Seven-hundred-fourteen hous
ehold contacts were not vaccinated, and served as controls. Among the
504 who were lepromin positive, leprosy developed in 35, all tuberculo
id, over the 8-year follow up. Among the 210 lepromin-negative unvacci
nated contacts, 61 developed leprosy: tuberculoid in 29, borderline in
4, lepromatous in 8, and indeterminate in 20. Overall, 13.5% of the 7
14 unvaccinated contacts and 29.0% of the 210 unvaccinated, lepromin-n
egative contacts developed leprosy. Vaccination could not induce lepro
min positivity in al contacts. The three vaccines were equally effecti
ve in inducing lepromin positivity. Vaccination reduced the overall in
cidence of leprosy from 13.5% to 7.8% among household contacts but did
not reduce the incidence of lepromatous leprosy (1.2% of all the vacc
inated and 1.1% of all the unvaccinated contacts).