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
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
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DOI：
10.1016/j.vaccine.2010.08.092
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发表时间：
2010-10-28
期刊：
影响因子：
5.5
通讯作者：
Piazza, Franco M.
中科院分区：
文献类型：
--
作者：
Llanos-Cuentas, Alejandro;Calderon, Wessmark;Piazza, Franco M.
粘膜利什曼病（ML）成人患者参加了一项随机、双盲、安慰剂对照、剂量递增的临床试验，并被随机分配接受三次LEISH-F1+MPL-SE疫苗注射，（由5 μ g 10或20 μ g重组利什曼原虫多蛋白LEISH-F1抗原+25 μ g MPL（R）-SE佐剂组成）（n = 36）或盐水安慰剂（n = 12）在第0、28和56天皮下给予研究注射，并且对患者进行安全性、免疫学和临床进展终点随访直至第336天。所有患者从第0天开始接受葡萄糖酸锑钠的标准化疗。此外，细胞内细胞因子染色显示记忆性LEISH-F1特异性IL-2（+）CD 4 T-细胞比例增加。该临床试验表明，LEISH-F1 + MPL-SE疫苗在ML患者中是安全和免疫原性的。(C)2010爱思唯尔有限公司版权所有
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