02780nas a2200325 4500000000100000008004100001260001300042653001000055653002600065653002300091653001100114653001100125653001200136653000900148653001600157653002500173653001900198653001500217100001300232700001300245700001300258700001100271245015100282856005900433300001100492490000700503050003200510520189800542022001402440 1993 d c1993 Jun10aAdult10aAntibodies, Bacterial10aBacterial Vaccines10aFemale10aHumans10aleprosy10aMale10aMiddle Aged10aMycobacterium leprae10aPilot Projects10aSkin Tests1 aChen Z L1 aTang Q G1 aWang Z M1 aChen J00aPilot study to determine acceptability and ability of heat-killed Mycobacterium leprae plus BCG (HKML+BCG) vaccine to induce skin test conversion. uhttp://leprev.ilsl.br/pdfs/1993/v64n2/pdf/v64n2a05.pdf a117-270 v64 aInfolep Library - available3 a

Although local reactions, including erythema, induration and ulcers, appeared in every patient after the injection of the combined HKML+BCG vaccine, they were accepted by the patients. There was no tendency for the local reaction to become aggravated after repeated vaccination. However, systemic reactions, mainly iridocyclitis and complaint of numbness of the fingers and toes, became quite common after the 5th vaccination and therefore significantly reduced the acceptability of vaccine by injection. It seems that repeated vaccination might activate the iridocyclitis, but the relationship between the complaint of numbness and vaccination has not been well established. Neither typical ENL nor reversal reaction had been observed throughout the trial. A significant proportion of patients converted to SMLA positivity after repeated vaccination. However, it seems the positive status was not stable as many of them reverted to negative after the following vaccination. After the 7th vaccination, the positive conversion rate to SMLA-I was 45% and to SMLA-II was 35%. After the 8th vaccination, 66.7% of patients converted to Mitsuda reaction positive, which has been confirmed by histopathological examination. Nevertheless, further follow-up is required in order to determine whether or not such conversion will be of a long duration. The reactions to SMLA-I and SMLA-II were associated but only correlated at a moderate level. Overall, the positive conversion rate to SMLA-I was significantly higher than that to SMLA-II after repeated vaccination. Neither the early reaction nor the late (Mitsuda) reaction of the lepromin test were correlated to either SMLA reaction. The repeated vaccination of HKML+BCG vaccine did not affect the weakly-positive anti-PGL-1 Mycobacterium leprae antibody level seen in the skin-smear negative lepromatous patients participating in this study.

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