02505nas a2200373 4500000000100000008004100001260001300042653001500055653001000070653002500080653002400105653001600129653003800145653001100183653001100194653002600205653002500231653000900256653001600265653002500281653001500306653001600321100001600337700001500353700001600368700001400384700001600398245017000414856009000584300001100674490000700685520142500692022001402117 1990 d c1990 Dec10aAdolescent10aAdult10aAnalysis of Variance10aAntigens, Bacterial10aBCG Vaccine10aEnzyme-Linked Immunosorbent Assay10aFemale10aHumans10aImmunotherapy, Active10aLeprosy, lepromatous10aMale10aMiddle Aged10aMycobacterium leprae10aSkin Tests10aVaccination1 aDouglas J T1 aHirsch D S1 aFajardo T T1 aGuido L S1 aKlatser P R00aSerological monitoring of previously treated lepromatous patients during a course of multiple immunotherapy treatments with heat-killed Mycobacterium leprae and BCG. uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1535489/pdf/clinexpimmunol00069-0147.pdf a567-730 v823 a

Two-hundred and seventy lepromatous patients who had completed treatment received multiple treatments with heat-killed M. leprae and BCG and were monitored for changes in humoral responses to M. leprae-specific antigens. These patients were divided into four treatment groups: placebo (n = 69); BCG (n = 68); M. leprae only (n = 71); and BCG + M. leprae (n = 62). They were monitored for 15 months, receiving five inoculations for each treatment regimen. Two ELISA systems, one measuring antibodies to M. leprae-specific epitopes of the phenolic glycolipid I (NDO-ELISA) and the other of 36-kD protein antigens (INH-ELISA) were used to measure serological changes during this period of immunotherapy. We found no significant increase in serological reactivity with the different treatments, as measured by NDO-ELISA. INH-ELISA similarly showed no significant changes, with the exception of increased values in a small group 13% (36/270) which became skin test-positive during the course of the study. The NDO-ELISA results indicate that use of heat-killed M. leprae or BCG + heat-killed M. leprae did not stimulate the humoral response to the semi-synthetic PG-I antigens of M. leprae. Thus, the NDO-ELISA may be useful in monitoring the outcome of vaccine trials in which killed M. leprae or M. leprae fractions are used, since seroconversion may indicate disease, rather than a response to the vaccine material.

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