The clinical efficacy of immunotherapy for localized American cutaneous leishmaniasis with a combination of heat-killed Leishmania mexicana amazonensis promastigotes and viable BCG (bacille Calmette Guérin) has been compared with meglumine antimoniate chemotherapy and with BCG alone in a controlled clinical study in 217 patients. The results in the first two groups were comparable, with greater than 90% clinical cures with an average time of 16-18 w required for healing. The cure rate was considerably lower (42%) and more prolonged in the group receiving BCG alone. Secondary effects were observed in less than 5% of the patients receiving combined immunotherapy or BCG alone. In contrast, 49% of the patients receiving chemotherapy showed side effects. High therapeutic efficacy was also observed using combined immunotherapy in patients with intermediate and diffuse cutaneous leishmaniasis who were previously unresponsive to chemotherapy. Cure or clinical improvement was seen in all 11 patients with intermediate forms of the disease, and marked clinical improvement was observed in 9 of 10 patients with diffuse disease. The results on the efficacy of the combined vaccine in immunotherapy for American cutaneous leishmaniasis provide a strong rationale for studying its effectiveness in prophylactic trials.
The clinico-pathologic spectrum ofleprosy in its diverse fo rms is the expression of the immunologic response of the human host to infection by My cobacterium leprae.In this spectrum, the ' lepromatous pole is characterized by a total lack of cell-mediated effector immunological responses; this lack is also seen to a lesser degree in borderline lepromatous (BL) as well as in other fo rms, which present a variable degree of deficiency of this type of immunity as they are located along the spectrum towards the tuberculoid pole of the disease.There is substantial evidence that the immunological defect which reaches its maximum expression in lepromatous patients is also present in other population groups, including a small portion of the healthy population. This evidence includes the fo llowing observations: (a) A significant proportion of patients with the indeterminate form of leprosy show immunological behaviour similar to that of the lepromatous patient, characterized by a lack of cell-mediated manifestations toward M. leprae. Without adequate treatment, this indeterminate form of leprosy shows a tendency to progress to lepromatous leprosy (LL). We have seen this phenomenon of progression towards the LL pole in indeterminate patients who, after many years of treatment, have stopped their medication due to various reasons and suddenly re-appear with LL or BL disease. On the other hand, indeterminate lesions in Mitsuda-positive patients show a tendency to regress spontaneously, or to evolve towards the highly resistant fo rms of the disease.' (b) Studies of the Mitsuda reaction in the general population, both in endemic and non-endemic areas, show that a small proportion of the general population is persistently Mitsuda-negative. In 1978 we studied the persist ence of this negativity towards lepromin in the population of a non-endemic area of Venezuela and found that 1·25% of the general population remained
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