Failure of Mycobacterium leprae soluble antigens to suppress delayed-type hypersensitivity reaction to tuberculin.

In order to test a published claim that the inclusion of Mycobacterium leprae antigens with a tuberculin skin test reagent can suppress delayed-type hypersensitivity (DTH) to tuberculin in both paucibacillary and multibacillary leprosy cases, 109 leprosy cases and 104 non-leprosy controls were skin-tested simultaneously with tuberculin with and without M. leprae soluble antigens. Tests were randomized between arms and carried out double-blind. There was a clear tendency for larger DTH responses with the combined tuberculin plus M. leprae antigen than with tuberculin alone in paucibacillary leprosy cases and in non-leprosy controls. No evidence for M. leprae antigen-mediated suppression of DTH was observed in any group. It is unclear whether the difference between the results reported here, which were obtained in Malawi, and those in the published literature which were obtained in India, is attributable to geographic differences in important biological variables or to differences in the experimental protocols. The need for methodological rigour in skin-test studies is stressed.