Clinical study to assess the immunogenicity and safety of a recombinant Pseudomonas aeruginosa OprF-OprI vaccine in burn patients
Clinical study to assess the immunogenicity and safety of a recombinant Pseudomonas aeruginosa OprF-OprI vaccine in burn patients
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DOI：
10.1016/s0928-8244(03)00072-5
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发表时间：
2003-07-15
影响因子：
--
通讯作者：
von Specht, BU
中科院分区：
文献类型：
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作者：
Mansouri, E;Blome-Eberwein, S;von Specht, BU
在最近的一项临床试验中，我们评估了由铜绿假单胞菌的成熟外膜蛋白I（OprI）和OprF的氨基酸190-342组成的重组OprF-OprI疫苗在烧伤患者中的安全性和免疫原性，并将所引发的抗体与针对破伤风的抗体作为对入院当天给予的同时免疫的应答进行比较。该疫苗的安全性和免疫原性已在1999年发表的健康人类志愿者中进行了测试。在第一次临床试验中，我们用100 μ g OprF-Opr I疫苗免疫了8名患有二度或三度烧伤的烧伤患者，烧伤面积在35%至55%之间，免疫三次。该疫苗的耐受性非常好。患者没有表现出任何严重的副作用-特别是没有观察到介质级联的激活。在烧伤治疗期间或之后，没有受试者显示出全身性铜绿假单胞菌感染。血清学试验（ELISA）检测抗铜绿假单胞菌和破伤风类毒素抗体显示接种后7例患者的血清转化。这些数据表明OprF-OprI可以是烧伤治疗管理中的有用疫苗。(C)2003年，欧洲微生物学会联合会。由Elsevier Science B. V.出版，版权所有。
In a recent clinical trial we evaluated the safety and immunogenicity of a recombinant OprF-OprI vaccine consisting of the mature outer membrane protein I (OprI) and amino acids 190-342 of OprF of Pseudomonas aeruginosa in burn patients and compared the elicited antibodies with antibodies against tetanus as response to a simultaneous immunization given on the day of admission. Safety and immunogenicity of the vaccine had been tested before in healthy human volunteers as published in 1999. In this first clinical trial we immunized eight burn patients suffering from second or third degree burns involving between 35% and 55% of the body surface three times with 100 mug of the OprF-OprI vaccine. The vaccine was found to be very well tolerated. The patients did not show any serious side effects - and in particular no activation of the mediator cascade was observed. None of the subjects showed systemic P. aeruginosa infections during or after the treatment of their burns. The serological tests (ELISA) for detection of antibodies against P. aeruginosa and tetanus toxoid showed seroconversion for seven patients after inoculation. The data indicate that OprF-OprI can be a useful vaccine in the therapeutic management of burn injuries. (C) 2003 Federation of European Microbiological Societies. Published by Elsevier Science B.V. All rights reserved.