* To establish the relationship between M.leprae infection and the development of immunity in a community in which multiple drug therapy (MDT) has been used for more than 10 years.
* To elucidate the pathogenesis of primary nasal infection in leprosy.
* To develop and test a chemotherapy-based intervention strategy for the interruption of leprosy transmission.
* Assessment of PCR positivity(putative infection) and immunity to leprosy in the endemic community.
* Whole population survey of 3 villages in India and one village in Africa. to obtain nasal swabs for polymer chain reaction(PCR) for M.leprae and specimens of saliva for measuring IgA levels against M.leprae.
* Child contact study. Samples will be obtained from 20 children from households with a treated leprosy patient and 20 controls at three monthly intervals over 3 years in 4 age groups.
* Assessment of immunity(IgA) and PCR positivity in newly exposed adults, with 3 monthly follow up over 3 years
* Assessment of the natural history of infection(PCR status) and immunity (Salivary IgA)in 30 adults identified in the MILEP1 study with 3 monthly follow-up.
* Development of simplified PCR and ELISA protocols (Miraj/AHRI/London/Bergen.
* ENT examination and nasal biopsy to be taken by an ENT surgeon of PCR positive individuals from village surveys which will be formalin fixed and sent to London for diagnosis and immuno-histo-chemistry for lymphocyte subsets in collaboration with Bergen.
Blood samples of PCR positive subjects to be obtained to determine cell mediated immunity(CMI)
* Double blind trial of single dose ofloxacin, rifampicin and minocycline in 60 new PCR positive subjects with monthly follow up for 6months and then 3 monthly measurement of PCR and salivary IgA to determine the course of infection.
* Intervention study to interrupt leprosy transmission. 'at risk' groups identified from activities 1-8 will be given a single dose of ofloxacin, rifampicin and minocycline with 3 monthly follow up.
Funding SchemeCSC - Cost-sharing contracts
2003 Addis Abeba
EC1V 9EL London