PLACEBO CONTROLLED CLINICAL-TRIAL OF TRANSFER-FACTOR IN LEPROMATOUS LEPROSY

  • 1 January 1979
    • journal article
    • research article
    • Vol. 35  (1) , 45-52
Abstract
The effects of repeated injections of transfer factor over a period of 20 wk were investigated in 14 bacteriologically positive patients at the lepromatous side of the leprosy spectrum. All patients showed negative (0 mm induration) skin tests to Mycobacterium leprae antigens [Ag] (i.e., leprolin and lepromin). Of these patients, 7 were treated with transfer factor with a total of 9 units (1 unit being equivalent to 5 .times. 108 lymphocytes) and 7 with a placebo. Maintenance treatment with clofazimine was continued. Transfer factor was prepared from the lymphocytes of donors who showed positive skin tests to M. leprae Ag (i.e., leprolin .gtoreq. 12 mm induration, average 15.5 mm or lepromin .gtoreq. 8 mm induration, average 13.6 mm) and a positive lymphocyte transformation in vitro to M. leprae (the average transformation being higher than the average transformation of lymphocytes of tuberculoid leprosy patients). No differences were found between the 2 groups as regards the clinical course of the disease, the histopathological and bacteriological evaluation of skin biopsies, changes in skin test reactivity to various Ag (i.e., lepromin, leprolin, PPD [purified protein derivative], Mumps, Candida albicans, Trichophyton rubrum and Varidase [streptokinase-streptodornase]), and the lymphocyte transformation in vitro to various mitogens (i.e., PHA [phytohemagglutinin], PWM [pokeweed mitogen], Con [concanavalin] A) and Ag (i.e., M. leprae, leprolin, PPD, BCG, Mumps, C. albicans, Trichophyton and Varidase). No evidence was found to suggest that transfer factor is a valuable adjuvant in the treatment of lepromatous leprosy patients or that it increases cell-mediated immune reactivity towards M. leprae.