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.

Nascimento E.; Fernandes D. F.; Vieira E. P.; Campos-Neto A.; Ashman J. A.; Alves F. P.; Coler R. N.; Bogatzki L. Y.; Kahn S. J.; Beckmann A. M.; Pine S. O.; Cowgill K. D.; Reed S. G.; Piazza F. M.

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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.

机译：一项临床试验，用于评估LEISH-F1 + MPL-SE疫苗与葡甲胺锑酸盐联用治疗皮肤利什曼病的安全性和免疫原性。

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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 micro g recombinant Leishmania polyprotein LEISH-F1 antigen+25 micro g MPLReg.-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.

机译：四十四名患有皮肤利什曼病（CL）的成年患者参加了一项随机，双盲，对照，剂量递增的临床试验，并随机分配接受三剂LEISH-F1 + MPL-SE疫苗的注射（包括5、10或20微克重组利什曼原虫多蛋白LEISH-F1抗原+25微克MPLReg.-SE佐剂（ n = 27），单独佐剂（ n = 8）或盐水安慰剂（ n = 9）。在第0、28和56天进行皮下注射研究性注射，并在第336天追踪患者的安全性，免疫学和临床发展终点。从第0天开始，所有患者均接受了葡甲胺锑酸盐的化疗。该疫苗安全且耐受良好。在第84天，几乎所有疫苗接受者，没有单独的佐剂或安慰剂接受者表现出针对LEISH-F1的IgG抗体反应。同样在第84天，80％的疫苗接受者被治愈，而单独使用佐剂的分别为50％和38％和安慰剂接受者。 LEISH-F1 + MPL-SE疫苗对CL患者安全且具有免疫原性，与葡甲胺锑酸盐化疗联用时，似乎缩短了治愈时间。 展开▼

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《Vaccine》 |2010年第40期|共7页

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Nascimento E.; Fernandes D. F.; Vieira E. P.; Campos-Neto A.; Ashman J. A.; Alves F. P.; Coler R. N.; Bogatzki L. Y.; Kahn S. J.; Beckmann A. M.; Pine S. O.; Cowgill K. D.; Reed S. G.; Piazza F. M.;
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正文语种 eng

中图分类医学免疫学;

关键词
adjuvants; adults; antigens; antiprotozoal agents; cutaneous leishmaniasis; drug therapy; human diseases; IgG; immune response; immunization; meglumine antimonate; randomized controlled trials; recombinant vaccines; safety; vaccination; Leishmania; man; South America; America; Developing Countries; Threshold Countries; Latin America; Trypanosomatidae; Kinetoplastida; Sarcomastigophora; Protozoa; invertebrates; animals; eukaryotes; Homo; Hominidae; Primates; mammals; vertebrates; Chord; ata; Brazil; Brazil; Minas Gerais; antigenicity; chemotherapy; glucantime; immune sensitization; immunity reactions; immunogens; immunological reactions.;

机译：佐剂;成人;抗原;抗原虫剂;皮肤利什曼病;药物治疗;人类疾病;IgG;免疫反应;免疫接种;葡甲胺锑酸盐;随机对照试验;重组疫苗;安全性;疫苗接种;利什曼原虫;人;南美;美洲;美国;发展中国家阈值国家;拉丁美洲;锥虫科;动毛虫科;肉食虫科;原生动物;无脊椎动物;动物;真核生物;人;人科;灵长类动物;哺乳动物;脊椎动物;和弦;ata;巴西化学;巴西;Minas Gerais;抗药性免疫反应免疫原免疫反应;

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专利

1. 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. [J] . Nascimento E., Fernandes D. F., Vieira E. P., Vaccine . 2010,第40期

机译：一项临床试验，用于评估LEISH-F1 + MPL-SE疫苗与葡甲胺锑酸盐联用治疗皮肤利什曼病的安全性和免疫原性。

2. 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. [J] . Llanos-Cuentas A., Calderon W., Cruz M., Vaccine . 2010,第46期

机译：评估LEISH-F1 + MPL-SE疫苗与stibogluconate钠联合用于治疗粘膜利什曼病的安全性和免疫原性的临床试验。

3. 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. [J] . Llanos-Cuentas A, Calderon W, Cruz M, Vaccine . 2010,第46期

机译：评估LEISH-F1 + MPL-SE疫苗与stibogluconate钠联合用于治疗粘膜利什曼病的安全性和免疫原性的临床试验。

4. PRE-CLINICAL AND CLINICAL INVESTIGATION OF THE SAFETY AND IMMUNOGENICITY OF A NOVEL INTRANASAL INFLUENZA VACCINE [C] . R. Glueck International symposium on controlled release of bioactive materials;Consumer diversified products conference . 2001

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5. Immunogenicity and Safety of Lactobacilli as Oral Mucosal Vaccine Vectors. [D] . Stoeker, Laura L. 2011

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6. Comparison between Combination Therapy of Oral Terbinafine and Cryotherapy versus Systemic Meglumine Antimoniate and Cryotherapy in Cutaneous Leishmaniasis: A Randomized Clinical Trial [O] . Saeedeh FARAJZADEH, Iraj ESFANDIARPOUR, Ali Akbar HAGHDOOST, 2015

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7. FACTORS ASSOCIATED TO ADHERENCE TO DIFFERENT TREATMENT SCHEMES WITH MEGLUMINE ANTIMONIATE IN A CLINICAL TRIAL FOR CUTANEOUS LEISHMANIASIS [O] . Madelon Novato Ribeiro, Maria Inês Fernandes Pimentel, Armando de Oliveira Schubach, 2014

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8. Comparison of Meglumine Antimoniate and Pentamidine for Peruvian Cutaneous Leishmaniasis [R] . Andersen, E. M. , Cruz-Saldarriaga, M. , Llanos-Cuentas, A. , 2005

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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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