Vaccination of human volunteers with heat-killed M. leprae: local responses in relation to the interpretation of the lepromin reaction.

The early (Fernandez) and late (Mitsuda) lepromin reactions were closely examined in a group of healthy, BCG-vaccinated individuals who were given four doses of a heat-killed, armadillo-derived vaccine, i.e., 1.5 X 10(7), 5 X 10(7), 1.5 X 10(8), and 5 X 10(8) bacilli. There was a clear dose-response relationship for both the early and late reactions with no leveling of the responses within the range of doses examined. While the early response was negative in most of the volunteers, the late response was positive in all of the volunteers. No association was found between the early lepromin test and the pre-vaccination skin test to PPD. There was also no association between the early lepromin test and the pre-vaccination skin test response to a soluble Mycobacterium leprae antigenic preparation (MLSA) in general, but there was a good correlation between these two parameters at the highest vaccine dose. The late lepromin response showed no association with either the prevaccination or post-vaccination skin test response to PPD. However, there was a significant correlation between the late lepromin response and the post-vaccination skin test response to MLSA. In general, no association could be found between the in vivo skin tests and the in vitro lymphocyte transformation test (LTT). Thus, the lepromin test is essentially a vaccination which elicits a specific response to M. leprae antigens provided that the dose of armadillo lepromin given is higher than 5 X 10(7). Therefore, it is unsuitable as a diagnostic test for leprosy.(ABSTRACT TRUNCATED AT 250 WORDS)