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首页> 外文期刊>Infection and immunity >Immunogenicity and Safety Testing of a Group B Intranasal Meningococcal Native Outer Membrane Vesicle Vaccine
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Immunogenicity and Safety Testing of a Group B Intranasal Meningococcal Native Outer Membrane Vesicle Vaccine

机译：B组鼻内脑膜炎球菌天然外膜囊泡疫苗的免疫原性和安全性测试

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The presently licensed meningococcal vaccine is a tetravalent capsular polysaccharide vaccine that induces immunity to serogroups A, C, Y, and W-135 but not to group B, which causes nearly half of the meningitis cases in the United States. The purpose of this study was to evaluate the safety and immunogenicity of an intranasal native outer membrane vesicle (NOMV) vaccine prepared from a capsule negative strain of group B of Neisseria meningitidis. In this study all volunteers received the same dose of vaccine, but we evaluated two different immunization schedules and the oropharyngeal and intranasal routes of vaccine delivery, assessed nasal cytology for cellular infiltration, and measured antibody-secreting cells (enzyme-linked immunospot assay [ELISPOT]) as an early marker for systemic immune response. Additionally, both intranasal and serum vaccine-specific antibodies were measured as well as serum bactericidal activity. Four groups with a total of 42 subjects were immunized on days 0, 28, and 56. Group 3 received an additional dose on day 7. Group 2 subjects were immunized both intranasally and oropharyngeally. Group 4 received a different lot of vaccine. All groups received approximately 1,200 μg of vaccine per subject. Patients were evaluated for side effects. The vaccine was well tolerated without evidence of inflammation on nasal cytology. The group receiving the extra vaccine dose showed the maximum increase in bactericidal activity. Thirty of 42 subjects demonstrated an increase in meningococcus-specific intranasal immunoglobulin A (IgA) titers, while 23 of 42 demonstrated an increase in specific IgG titers. The group receiving vaccine intranasally and oropharyngeally showed the highest rise in intranasal titers for both IgA and IgG. Groups 1, 3, and 4 showed a significant increase in antibody-secreting cells on ELISPOT. Eighteen of 42 volunteers demonstrated a fourfold or greater rise in bactericidal titers, with 81% showing an increase over baseline. We have demonstrated the immunogenicity and safety of a group B lipopolysaccharide-containing, intranasal, NOMV vaccine.
机译：目前获得许可的脑膜炎球菌疫苗是一种四价荚膜多糖疫苗，可诱导对A，C，Y和W-135血清群的免疫，但对B组没有免疫力，而B组在美国引起了近半数的脑膜炎病例。这项研究的目的是评估由脑膜炎奈瑟氏球菌B组的胶囊阴性菌株制备的鼻内天然外膜囊泡（NOMV）疫苗的安全性和免疫原性。在这项研究中，所有志愿者都接受了相同剂量的疫苗，但我们评估了两种不同的免疫方案以及疫苗递送的口咽和鼻内途径，评估了鼻腔细胞学对细胞浸润的影响，并测量了分泌抗体的细胞（酶联免疫斑点法[ELISPOT]）作为早期标记全身免疫反应。另外，还测量了鼻内和血清疫苗特异性抗体以及血清杀菌活性。在第0、28和56天对总共42名受试者的4组进行了免疫。第3组在第7天接受了额外的剂量。第2组受试者在鼻内和口咽部进行了免疫。第4组接种了不同批次的疫苗。所有组每个受试者接受约1,200μg疫苗。对患者进行了副作用评估。疫苗耐受良好，鼻细胞学检查无炎症迹象。接受额外疫苗剂量的组显示出最大的杀菌活性。 42名受试者中有30名表现出脑膜炎球菌特异性鼻内免疫球蛋白A（IgA）滴度增加，而42名受试者中有23名表现出特异性IgG滴度增加。鼻内和口咽接受疫苗的人群对IgA和IgG的滴鼻滴度上升最高。第1、3和4组显示ELISPOT上抗体分泌细胞的显着增加。 42名志愿者中有18名表现出杀菌效价的四倍或更高增长，其中81％的人表现出比基线更高。我们已经证明了含B组脂多糖的鼻内NOMV疫苗的免疫原性和安全性。

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