Safety and immunogenicity testing of an intranasal group B meningococcal native outer membrane vesicle vaccine in healthy volunteers
Safety and immunogenicity testing of an intranasal group B meningococcal native outer membrane vesicle vaccine in healthy volunteers
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DOI：
10.1016/s0264-410x(99)00216-9
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发表时间：
1999-08-20
期刊：
影响因子：
5.5
通讯作者：
Zollinger, WD
中科院分区：
文献类型：
--
作者：
Drabick, JJ;Brandt, BL;Zollinger, WD
由未暴露于去污剂或变性剂的天然外膜囊泡 (NOMV) 组成的鼻内疫苗是由 B 组脑膜炎球菌菌株 9162 SynX(-)(-:15:P1.3:P5.10,11:L3,7,9) 制备的，并在 32 名健康成年志愿者中进行了测试。四组 8 名志愿者鼻内接种了三剂疫苗。尽管疫苗中脂寡糖的含量相对于蛋白质为 25%，但该疫苗在所有剂量组中均具有良好的耐受性。 ELISA测定血清、唾液和鼻腔冲洗液中的抗体反应在所有4组中均相对较低，但诱导的血清抗体具有较强的杀菌活性。 75% 的接受者产生了持久的杀菌抗体（增加大于或等于 4 倍）。一些杀菌抗体与不同的 B 组菌株发生交叉反应。大多数杀菌抗体似乎对 PorA 和 L3,7,9 LOS 具有特异性。该疫苗还产生了局部抗体反应，在志愿者的洗鼻液中检测到了这种反应。这些数据表明，NOMV鼻腔免疫是诱导针对B群脑膜炎球菌的全身和局部免疫的安全有效的方法，值得进一步研究。由爱思唯尔科学有限公司出版
An intranasal vaccine composed of native outer membrane vesicles (NOMV) not exposed to detergent or denaturing agents was prepared from the group B meningococcal strain 9162 SynX(-)(-:15:P1.3:P5.10,11:L3,7,9) and tested in 32 healthy adult volunteers. Four groups of 8 volunteers were vaccinated intranasally with three doses of vaccine. The vaccine was very well tolerated in all dosing groups, despite the presence of lipo-oligosaccharide in the vaccine at a level of 25% relative to protein. The antibody response as measured by ELISA in serum, saliva and nasal wash fluids was relatively low in all 4 groups, but the induced serum antibodies had strong bactericidal activity. Persistent bactericidal antibodies (greater than or equal to 4-fold increase) were produced in 75% of the recipients. Some of the bactericidal antibodies were cross reactive against divergent group B strains. Most of the bactericidal antibodies appeared to be specific for PorA and L3,7,9 LOS. The vaccine also produced a local antibody response which was detected in the nasal wash fluids of volunteers. These data suggest that nasal immunization with NOMV is a safe and effective approach to induce systemic and local immunity against the group B meningococcus and deserves further study. Published by Elsevier Science Ltd.