A collaborative study has been undertaken to establish the relationship bet
ween infection by Mycobacterium leprae and the development of immunity in a
community in which multidrug therapy (MDT) has been used for more than 10
years, to elucidate the pathogenesis of infection in leprosy, and to develo
p and test an intervention strategy based on chemotherapy for interruption
of transmission of the organism in the community. The first phase of the st
udy included the establishment of laboratory facilities and pilot work in I
ndia. In the course of the second phase, the entire populations of three vi
llages in India and one in Ethiopia have been surveyed, nasal swabs were ob
tained for detection of M. leprae DNA by means of the polymerase chain reac
tion (PCR), specimens of saliva were obtained for measurement of levels of
anti-M. leprae IgA antibodies, and follow-up surveys have been carried out.
A double-blind trial of chemotherapy among subjects whose PCR was positive
is proposed, to determine if the course of the infection can be influenced
by treatment. The performance of large numbers of PCR tests in endemic cou
ntries has required the development of rigorous internal and external quali
ty control procedures. These have shown that many batches (as many as 50%)
fail to meet quality control criteria, and must be retested. Despite this,
development of these methods, and their application to field studies should
provide tools for studying the transmission of M. leprae, and direct metho
ds of testing innovative interventions.