Immunochemotherapy of persistent post-kata-azar dermal leishmaniasis: a novel approach to treatment

Post-kala-azar dermal leishmaniasis (PKDL) is a recognized dermatosis that follows successful treatment of visceral leishmaniasis in the Sudan. This randomized and double-blind study aimed to assess safety, immunogenicity and curative potentials of a novel immunochemotherapy regimen in patients with persistent PKDL. Following informed consent, 30 patients were randomized to receive alum-precipitated autoclaved Leishmania major (Alum/ALM) vaccine + Bacille Calmette-Guerin (BCG) and sodium stibogluconate (SSG) or vaccine diluent and SSG. The SSG +Alum/ALM+BCG proved safe with minimal. local adverse events. In the SSG+vaccine group, 87% of the patients were cured by day 60 compared with 53% in the SSG atone group (SSG+vaccine efficacy = 71%, 95% CI for risk ratio 0.7-1.16). On day 90 of follow-up there were two relapses in the SSG alone arm and none in the SSG+vaccine arm. Pretreatment cytokines showed high IFN-gamma or high IFN-gamma/IL-10 levels and leishmanin skin test (LST) non-reactivity, white healing/clinical improvement were associated with LST reactivity and low IFN-gamma levels in both study groups (P=0.004). In conclusion, SSG+Alum/ALM+BCG is safe and immunogenic with significant heating potentials in persistent PKDL lesions. Immunochemotherapy probably augmented IFN-gamma production, which induced heating. Leishmanin skin reactivity is a good surrogate marker of cure in persistent PKDL lesions. (c) 2007 Royal Society of Tropical Medicine and Hygiene. Published by Elsevier Ltd. All rights reserved.