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首页> 外文期刊>Vaccine >Safety, immunogenecity, and efficacy of an autoclaved Leishmania amazonensis vaccine plus BCG adjuvant against New World cutaneous leishmaniasis
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Safety, immunogenecity, and efficacy of an autoclaved Leishmania amazonensis vaccine plus BCG adjuvant against New World cutaneous leishmaniasis

机译：高压灭菌的亚马逊利什曼原虫疫苗加BCG佐剂对新大陆皮肤利什曼病的安全性，免疫原性和功效

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摘要

The safety, immunogenecity, and efficacy of two doses of an autoclaved-killed, whole cell Leishmania amazonensis vaccine (IFLA/BR/ 67/PH8) and BCG adjuvant (n = 750) against cutaneous leishmaniasis (CL) was compared with placebo (n = 756) in a randomized, placebo-controlled, blinded study. Systemic and local side-effects were more frequent in the vaccine than placebo group. Leishmanin skin test (LST) conversion was greater in the vaccine than placebo group 2 months after the second vaccination dose (74.4% versus 14.7%; P = 0.000001). The 26-month incidence of confirmed CL (n = 25) was similar between the vaccine (2.0%) and placebo groups (2.0% versus 1.3%; P > 0.05). LST conversion was not associated with CL protection and the vaccine did not offer significant protection against CL infection caused by L. Viannia spp. compared to placebo
机译：比较了两剂经高压灭菌的全细胞亚马逊利什曼原虫疫苗（IFLA / BR / 67 / PH8）和BCG佐剂（n = 750）对皮肤利什曼病（CL）的安全性，免疫原性和功效，与安慰剂（n （= 756）在一项随机，安慰剂对照，双盲研究中。与安慰剂组相比，疫苗中的全身和局部副作用更为常见。第二次接种疫苗后2个月，疫苗中的利什曼宁皮肤试验（LST）转化率高于安慰剂组（74.4％对14.7％; P = 0.000001）。疫苗（2.0％）和安慰剂组之间26个月确诊CL的发生率（n = 25）相似（2.0％vs 1.3％; P> 0.05）。 LST的转化与CL的保护无关，疫苗也没有针对L. Viannia spp引起的CL感染提供显着的保护。与安慰剂相比

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