02454nas a2200337 4500000000100000008004100001260001300042653002700055653001200082653001500094653001600109653002000125653004400145653001600189653003000205653002300235653001700258653001200275653002400287653002500311653002800336653001500364653001500379100001200394700001400406245008000420300001100500490000700511520158400518022001402102 1979 d c1979 Mar10aAdjuvants, Immunologic10aAnimals10aArmadillos10aBCG Vaccine10aCross Reactions10aDose-Response Relationship, Immunologic10aGuinea Pigs10aHypersensitivity, Delayed10aImmunity, Cellular10aImmunization10aleprosy10aMycobacterium bovis10aMycobacterium leprae10aPharmaceutical Vehicles10aSkin Tests10aSonication1 aMehra V1 aBloom B R00aInduction of cell-mediated immunity to Mycobacterium leprae in guinea pigs. a787-940 v233 a

Guinea pigs immunized with intact or disrupted armadillo-grown human Mycobacterium leprae administered in aqueous or oil vehicles were tested with various dilutions of M. leprae suspended in saline, water-soluble M. leprae extract, purified protein derivative, and a water-soluble extract of normal armadillo tissue. The results demonstrated the following. (i) Under no conditions was any skin test reactivity found to normal armadillo tissue extract. (ii) Positive sensitization to both M. leprae and its water-soluble extract was achieved by sensitizing guinea pigs with M. leprae suspended in Hanks solution or saline. Autoclaved M. leprae in Hanks solution or saline inoculated intradermally was an effective immunogen. Oil suspensions or emulsions were effective at sensitization, but appeared to be no better and, in general, slightly weaker, than simple inoculation in aqueous suspension. (iii) Living BCG failed to reveal a significant adjuvant effect on sensitization to M. leprae. However, cord factor appeared to potentiate slightly the sensitization to M. leprae in aqueous suspension. (iv) The minimum dose required for sensitization with M. leprae in aqueous suspension was 55 micrograms of purified bacilli. (v) Animals inoculated with M. leprae in saline or with M. leprae together with BCG showed positive skin test reactivity to the first skin test application made fully 1 year after the initial sensitization. The efficacy of autoclaved, irradiated M. leprae in aqueous, oil-free medium suggests a relatively safe approach to human vaccination studies.

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