Human immune response to a Pseudomonas aeruginosa outer membrane protein vaccine
Human immune response to a Pseudomonas aeruginosa outer membrane protein vaccine
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DOI：
10.1016/s0264-410x(98)00159-5
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发表时间：
1999-01-01
期刊：
影响因子：
5.5
通讯作者：
Kim, HS
中科院分区：
文献类型：
--
作者：
Jang, IJ;Kim, IS;Kim, HS
为了评估由外膜蛋白（OMP）CFC-101组成的铜绿假单胞菌疫苗在人体中的安全性和免疫原性，我们在健康男性志愿者中进行了I/IIa期临床试验。六名志愿者组成的小组以 7 天的间隔用三种剂量的疫苗进行皮下 (s.c.) 或肌内 (i.m.) 免疫接种 3 次。志愿者对该疫苗的耐受性良好。注射部位的局部反应通常是轻微且短暂的。接种疫苗后，两个途径组中均观察到 OMP 特异性抗体显着增加，但肌内免疫组的水平更高，其中 0.5 或 1.0 mg 剂量的疫苗接种产生 100% 血清转化。通过蛋白质印迹分析和免疫沉淀测定证明了诱导的铜绿假单胞菌 OMP 抗体的特异性。 Clq结合能力的增加以及赋予小鼠免受铜绿假单胞菌致死攻击的保护的能力表明了引发的抗体的保护功效。根据这些数据，我们得出结论，铜绿假单胞菌 OMP 疫苗对人类是安全有效的，最佳剂量为 0.5 和 1.0 mg，并且肌内注射。是比 s.c. 更好的路线对于这种疫苗。 (C) 1998 Elsevier Science Ltd. 保留所有权利。
In order to evaluate in humans the safety and immunogenicity of a Pseudomonas aeruginosa vaccine composed of outer membrane proteins (OMPs), CFC-101, we carried out a phase I/IIa clinical trial in healthy male volunteers. Groups of six volunteers were immunized either subcutaneously (s.c.) or intramuscularly (i.m.) with three dosages of the vaccine three times at 7-day intervals. The vaccine was well tolerated by volunteers. Local reactions in the injection sites were generally mild and transient. Significant increases in OMP-specific antibody were observed in both route groups after vaccinations but was higher in the i.m.-immunized group, where vaccination with 0.5 or 1.0 mg doses yielded 100% seroconversion. The specificity of the induced antibodies to P. aeruginosa OMP was demonstrated by western blot analysis and immunoprecipitation assay. An increase in Clq-binding capacity and ability to confer mice protection from lethal challenges with P. aeruginosa indicated the protective efficacy of the elicited antibodies. Based on these data, we concluded that the P. aeruginosa OMP vaccine is safe and effective in humans with an optimal dose of 0.5 and 1.0 mg and that i.m. is the better route than s.c. for this vaccine. (C) 1998 Elsevier Science Ltd. All rights reserved.