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首页> 美国卫生研究院文献>Clinical and Diagnostic Laboratory Immunology >Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM197 Conjugate Vaccine against Serogroups A C W-135 and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates
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Immunogenicity and Safety of a Multicomponent Meningococcal Serogroup B Vaccine and a Quadrivalent Meningococcal CRM197 Conjugate Vaccine against Serogroups A C W-135 and Y in Adults Who Are at Increased Risk for Occupational Exposure to Meningococcal Isolates

机译：在职业性脑膜炎球菌分离株暴露风险较高的成年人中多组分脑膜炎球菌血清B群疫苗和四价脑膜炎球菌CRM197的免疫原性和安全性结合疫苗可抵抗血清ACW-135和Y群。

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Laboratory staff who work with meningococcal isolates are at increased risk for developing invasive disease relative to the general population. This was the first study of laboratory workers who received both a conjugate vaccine against meningococcal serogroups A, C, W-135, and Y (Men ACWY-CRM, Menveo) and an investigational multicomponent vaccine against serogroup B containing factor H binding protein, neisserial adhesin A, Neisseria heparin binding antigen, and New Zealand strain outer membrane vesicles (4CMenB). Healthy adults (18 to 50 years of age) received three doses of 4CMenB at baseline, 2 months, and 6 months followed by a single dose of MenACWY-CRM 1 month later. Immunogenicity was assessed via serum bactericidal assay using human complement (hSBA) at 1 month postvaccination; solicited reactogenicity and adverse events were monitored. Fifty-four participants enrolled. Bactericidal immune responses were evident after each dose of 4CMenB, as assessed by hSBA geometric mean titers and percentages of subjects with hSBA titers of ≥4 against the test strains or a 4-fold rise in titer over baseline. At 1 month postvaccination, most MenACWY-CRM recipients had hSBA titers of ≥8 against serogroups A, C, W-135, and Y. Few participants discontinued due to an adverse event or vaccine reaction. Rates of solicited reactions were lower after MenACWY-CRM than after 4CMenB administration. Sequential administration of 4CMenB and MenACWY-CRM provided robust evidence of an immune response against serogroups A, B, C, W-135, and Y in laboratory workers routinely exposed to meningococcal isolates.
机译：与一般人群相比，从事脑膜炎球菌分离株工作的实验室工作人员患侵袭性疾病的风险增加。这是对实验室工作人员进行的首项研究，他们既接受了针对脑膜炎球菌A，C，W-135和Y的结合疫苗（Men ACWY-CRM，Menveo），又接受了针对含有B型血清因子H结合蛋白的奈瑟球菌的多组分疫苗的研究粘附素A，奈瑟氏球菌肝素结合抗原和新西兰菌株外膜囊泡（4CMenB）。健康的成年人（18至50岁）在基线，2个月和6个月接受三剂4CMenB，然后在1个月后接受单剂MenACWY-CRM。免疫后1个月，使用人补体（hSBA）通过血清杀菌试验评估免疫原性；监测引起的反应原性和不良事件。共有54位参与者参加。通过hSBA几何平均滴度和hSBA滴度≥4的受试者对测试菌株的滴度或滴定度比基线高4倍，评估出每剂4CMenB后的杀菌免疫反应是明显的。接种疫苗后1个月，大多数MenACWY-CRM接受者针对A，C，W-135和Y血清群的hSBA效价≥8。很少有参与者因不良事件或疫苗反应而停药。 MenACWY-CRM后的征服反应率低于4CMenB给药后。顺序施用4CMenB和MenACWY-CRM提供了强有力的证据，证明了常规暴露于脑膜炎球菌分离株的实验室工作人员针对血清A，B，C，W-135和Y的免疫应答。

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