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成人用A群和C群脑膜炎球菌多糖结合疫苗的安全性及免疫原性

Safety and immunogenicity of meningococcal A and C polysaccharide conjugate vaccine in adults.

作者信息

Anderson E L, Bowers T, Mink C M, Kennedy D J, Belshe R B, Harakeh H, Pais L, Holder P, Carlone G M

机构信息

Department of Medicine, Saint Louis University School of Medicine, Missouri.

出版信息

Infect Immun. 1994 Aug;62(8):3391-5. doi: 10.1128/iai.62.8.3391-3395.1994.

Abstract

A meningococcal vaccine containing group A and C polysaccharides conjugated to CRM197 was evaluated in 50 adults. Vaccinees were entered into one of five groups: 30 adults received a single dose of either 22, 11, or 5.5 micrograms of the conjugated A-C vaccine; 10 received an approved meningococcal vaccine; and 10 received saline injections. Local and systemic reactions to vaccines were recorded, and immune responses were determined. The experimental meningococcal vaccine was well tolerated, with the most frequent reaction being pain at the injection site. Both A and C polysaccharide components of the experimental vaccine were highly immunogenic, and total antibody concentrations 1 month postvaccination were not significantly different from the mean antibody concentrations among adults given the approved meningococcal vaccine. In addition, significant rises in immunoglobulin G, A, and M antibodies to both A and C polysaccharides occurred. Antibody concentrations measured at 6 and 12 months postvaccination had declined but remained significantly higher than prevaccination concentrations. Postvaccination meningococcal group C functional antibody activity increased more than 600-fold for both the polysaccharide and the conjugate vaccines. Further studies of this conjugated meningococcal vaccine are indicated for young children and infants.

摘要

一种含有与CRM197偶联的A群和C群多糖的脑膜炎球菌疫苗在50名成年人中进行了评估。接种者被分为五组之一:30名成年人接受单剂量22、11或5.5微克的A-C结合疫苗;10名接受已获批准的脑膜炎球菌疫苗;10名接受盐水注射。记录了对疫苗的局部和全身反应,并测定了免疫反应。实验性脑膜炎球菌疫苗耐受性良好,最常见的反应是注射部位疼痛。实验疫苗的A群和C群多糖成分均具有高度免疫原性,接种疫苗1个月后的总抗体浓度与接种已获批准的脑膜炎球菌疫苗的成年人中的平均抗体浓度无显著差异。此外,针对A群和C群多糖的免疫球蛋白G、A和M抗体均有显著升高。接种疫苗后6个月和12个月测得的抗体浓度有所下降,但仍显著高于接种前浓度。接种疫苗后脑膜炎球菌C群功能性抗体活性对于多糖疫苗和结合疫苗均增加了600多倍。对于幼儿和婴儿,需要对这种结合型脑膜炎球菌疫苗进行进一步研究。

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