一种新型C群脑膜炎奈瑟菌-破伤风类毒素结合疫苗在健康成年人中的安全性和免疫原性。
Safety and immunogenicity of a new Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in healthy adults.
作者信息
Richmond P, Goldblatt D, Fusco P C, Fusco J D, Heron I, Clark S, Borrow R, Michon F
机构信息
Immunobiology Unit, Institute of Child Health, 30 Guilford Street, London, UK.
出版信息
Vaccine. 1999 Nov 12;18(7-8):641-6. doi: 10.1016/s0264-410x(99)00276-5.
UNLABELLED
We evaluated the safety and immunogenicity of a single dose of a new serogroup C O-deacetylated meningococcal polysaccharide-tetanus toxoid conjugate vaccine in 30 healthy adult volunteers. The vaccine was well tolerated with no serious adverse events and minimal local reactions and systemic symptoms. All subjects developed a fourfold or greater increase in serum bactericidal antibody (SBA) to serogroup C meningococcus. SBA geometric mean titre increased from 11 to 3649 (p<0.001). Serogroup C-specific IgG levels increased postvaccination from 0.65 to 17.02 microg/ml (p<0.001). Bactericidal titres pre- and postimmunisation showed significant correlation with serogroup C-specific IgG (r(2)=0.693). Antibody levels fell by 6 months postvaccination, however, meningococcal C IgG avidity increased indicating the successful induction of a T-cell-dependent antibody response.
CONCLUSION
meningococcal C-tetanus toxoid conjugate vaccine is immunogenic and well tolerated in healthy adults.
未标注
我们评估了单剂量新型C群O-脱乙酰化脑膜炎球菌多糖-破伤风类毒素结合疫苗在30名健康成年志愿者中的安全性和免疫原性。该疫苗耐受性良好，无严重不良事件，局部反应和全身症状轻微。所有受试者针对C群脑膜炎球菌的血清杀菌抗体（SBA）均出现四倍或更高的增长。SBA几何平均滴度从11增至3649（p<0.001）。接种疫苗后，C群特异性IgG水平从0.65微克/毫升增至17.02微克/毫升（p<0.001）。免疫前后的杀菌滴度与C群特异性IgG呈显著相关性（r(2)=0.693）。接种疫苗6个月后抗体水平下降，然而，脑膜炎球菌C IgG亲和力增加，表明成功诱导了T细胞依赖性抗体反应。
结论
脑膜炎球菌C-破伤风类毒素结合疫苗在健康成年人中具有免疫原性且耐受性良好。
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