一种新型三价脑膜炎球菌多糖疫苗的免疫原性和安全性评估。
An evaluation of the immunogenicity and safety of a new trivalent meningococcal polysaccharide vaccine.
作者信息
Chandramohan Daniel, Hodgson Abraham, Coleman Paul, Baiden Rita, Asante Kwaku, Awine Elizabeth, Owusu-Agyei Seth, Boutriau Dominique, Nelson Christopher B, Greenwood Brain
机构信息
London School of Hygiene & Tropical Medicine, Keppel Street, London WC1E 7HT, UK.
出版信息
Vaccine. 2007 Sep 3;25 Suppl 1:A83-91. doi: 10.1016/j.vaccine.2007.04.047. Epub 2007 May 7.
The immunogenicity and safety of a meningococcal trivalent A/C/W135 polysaccharide vaccine was compared with that of a tetravalent A/C/Y/W135 polysaccharide vaccine in a randomised, double blind trial. The study included 360 adults, who received either a trivalent or tetravalent polysaccharide meningococcal vaccine. Antibody responses were determined by serum bactericidal antibody (rSBA) assays prior to vaccination and on day 28 and month 11 after vaccination. The percentage of participants in the trivalent vaccine group who had rSBA titres >or=8 on day 28 post-vaccination against serogroups A, C and W135 meningococci were 99, 98 and 91%, respectively. The corresponding figures in the tetravalent vaccine group were 99, 99 and 90%. The percentage of participants with various cut off levels of rSBA against serogroups A, W135 and C meningococci on day 28 and 11-month post-vaccination and the incidence of adverse events did not differ significantly between the two groups.
在一项随机双盲试验中，对三价A/C/W135脑膜炎球菌多糖疫苗和四价A/C/Y/W135多糖疫苗的免疫原性和安全性进行了比较。该研究纳入了360名成年人，他们分别接种了三价或四价多糖脑膜炎球菌疫苗。在接种疫苗前以及接种后第28天和第11个月，通过血清杀菌抗体（rSBA）检测来确定抗体反应。接种疫苗后第28天，三价疫苗组中针对A、C和W135血清群脑膜炎球菌的rSBA滴度≥8的参与者百分比分别为99%、98%和91%。四价疫苗组的相应数字分别为99%、99%和90%。接种疫苗后第28天和第11个月时，两组中针对A、W135和C血清群脑膜炎球菌不同rSBA截断水平的参与者百分比以及不良事件发生率均无显著差异。
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