A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with sodium stibogluconate for the treatment of mucosal leishmaniasis

Adult patients with mucosal leishmaniasis (ML) were enrolled in a randomized double-blind placebo-controlled dose-escalating clinical trial and were randomly assigned to receive three injections of either the LEISH-F1+MPL-SE vaccine (consisting of 5 10 or 20 mu g recombinant Leishmania polyprotein LEISH-F1 antigen +25 mu g MPL (R)-SE adjuvant) (n = 36) or saline placebo (n = 12) The study injections were given subcutaneously on Days 0 28 and 56 and the patients were followed through Day 336 for safety immunological and clinical evolution endpoints All patients received standard chemotherapy with sodium stibogluconate starting on Day 0 The vaccine was safe and well tolerated and induced both humoral and cell-mediated Immune responses Furthermore intracellular cytokine staining showed an Increase in the proportion of memory LEISH-F1-specific IL-2(+) CD4 T-cells after vaccination which was associated with clinical cure This clinical trial shows that the LEISH-F1 + MPL-SE vaccine is safe and immunogenic in patients with ML. (C) 2010 Elsevier Ltd All rights reserved