PRECLINICAL SAFETY AND IMMUNOGENICITY OF GROUP B MENINGOCOCCAL VACCINES

不同免疫球蛋白诱导的恒河猴抗体的结合特异性 对B群脑膜炎奈瑟菌结合疫苗进行了研究 使用多种B群脑膜炎球菌多糖（GBPS）抗原 系统. 如通过ELISA测量的，抗体应答显著高于对照组。 高于含间隔基的GBPS或GBPS的N-丙酰化形式 与甲基化人血清白蛋白复合的天然GBPS相比 （HSA）。 针对所述抗体的抗体群体的特异性可以被称为特异性抗体。 间隔区，ADH，证实了他们的结合无关的肺炎球菌 9V多糖通过ADH与HSA缀合。 引发的抗体 GBPS-OMV结合疫苗也显示与N-丙酰化GBPS结合 与HSA结合。 来自各种疫苗的高应答者的合并血清 组显示出不同程度的调理吞噬活性， 猴补体 作为先前免疫接种时间表的延伸， 在第2周，用纯化的GBPS单独免疫猴子， 50，然后在第72周用GBNM的灭活全细胞疫苗。 而 用纯GBPS进行加强免疫， 抗体水平显着，免疫与杀死细胞产生 全细胞抗原的抗体。 既不是用缀合物多次免疫，也不是再免疫 使用GBPS或灭活全细胞疫苗， 猴子的安全相关症状。

The binding specificity of rhesus antibodies elicited by various conjugate vaccines of group B Neisseria meningitidis (GBNM) was studied using a variety of group B meningococcal polysaccharide (GBPS) antigen systems. The antibody response, as measured by ELISA, was significantly higher to the spacer-containing GBPS or N-propionylated version of GBPS than to the native GBPS complexed with methylated human serum albumin (HSA). The specificity of a population of antibodies directed to the spacer, ADH, was confirmed by their binding to an unrelated pneumococcal 9V polysaccharide conjugated to HSA through ADH. Antibodies elicited by GBPS-OMV conjugate vaccine also showed binding to N-propionylated GBPS conjugated to HSA. Pooled sera of high responders from various vaccine groups showed varied degree of opsonophagocytic activity in presence of monkey complement. As an extension of the previous immunization schedule, four groups of monkeys were further immunized first with the purified GBPS alone at week 50 and then with killed whole cell vaccine of GBNM at week 72. While the booster immunization with pure GBPS did not increase the capsular antibody levels significantly, immunization with killed cells produced antibodies to the whole cell antigen. Neither multiple immunizations with the conjugates nor reimmunization with GBPS or killed whole cell vaccine resulted in any discernible safety-related symptoms in the monkeys.