A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis
A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine when used in combination with meglumine antimoniate for the treatment of cutaneous leishmaniasis
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DOI：
10.1016/j.vaccine.2010.07.063
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发表时间：
2010-09-14
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：
Nascimento, Evaldo;Fernandes, Demetrios F.;Piazza, Franco M.
44名皮肤利什曼病（CL）成人患者参加了一项随机、双盲、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、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 =27），单独佐剂（n = 8），或生理盐水安慰剂（n = 9）。在第0、28和56天皮下注射研究注射剂，并对患者进行随访直至第336天，以获得安全性、免疫学和临床演变终点。所有患者从第0天开始接受锑酸葡甲胺化疗。该疫苗是安全的，耐受性良好。在第84天，几乎所有的疫苗接种者和单独的免疫剂或安慰剂接种者都表现出对LEISH-F1的IgG抗体应答。同样在第84天，80%的疫苗接种者临床治愈，而单独接种和安慰剂接种者分别为50%和38%。LEISH-F1 + MPL-SE疫苗对CL患者是安全的且具有免疫原性，并且与锑酸葡胺化疗联合使用时似乎可以缩短他们的治愈时间。(c)2010爱思唯尔有限公司版权所有。
Forty-four adult patients with cutaneous leishmaniasis (CL) were enrolled in a randomized, double-blind, 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 recombinant Leishmania polyprotein LEISH-F1 antigen + 25 mu g MPL (R)-SE adjuvant) (n =27), adjuvant alone (n = 8), or saline placebo (n = 9). 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 chemotherapy with meglumine antimoniate starting on Day 0. The vaccine was safe and well tolerated. Nearly all vaccine recipients and no adjuvant-alone or placebo recipients demonstrated an IgG antibody response to LEISH-F1 at Day 84. Also at Day 84, 80% of vaccine recipients were clinically cured, compared to 50% and 38% of adjuvant-alone and placebo recipients. The LEISH-F1 + MPL-SE vaccine was safe and immunogenic in CL patients and appeared to shorten their time to cure when used in combination with meglumine antimoniate chemotherapy. (c) 2010 Elsevier Ltd. All rights reserved.