Brandt B L, Artenstein M S, Smith C D
Infect Immun. 1973 Oct;8(4):590-6. doi: 10.1128/iai.8.4.590-596.1973.
Over the past 4 years 19 lots of group C polysaccharide vaccine and five lots of group A polysaccharide vaccine have been tested for their immunogenicity in man. For each lot tested, groups of 18 to 50 men received 50 mug of vaccine subcutaneously. Sera were obtained prior to and 2 weeks after vaccination. The analytical and serological methods used in these studies were Sepharose 4B chromatography for the estimation of molecular size, the radioactive antigen binding assay, and the indirect hemagglutination (IHA) test for measuring the antibody response. Results have shown that the radioactive antigen binding assay is preferable to the IHA test as a measure of antibody response. Group C meningococcal vaccines have been highly stable when stored at 4 C in powdered form. All lots of group C vaccine tested to date have been of equal potency, with molecular weight varying from 520,000 to 2,000,000. Group A polysaccharides have been found to be unstable after 2 years of storage at 4 C. Optimal antibody response to the group A vaccines appears to be directly related to the molecular size of the preparation.
在过去4年中,对19批C群多糖疫苗和5批A群多糖疫苗进行了人体免疫原性测试。对于每一批测试疫苗,18至50名男性组成的小组皮下注射50微克疫苗。在接种疫苗前和接种后2周采集血清。这些研究中使用的分析和血清学方法包括用于估计分子大小的琼脂糖4B色谱法、放射性抗原结合试验以及用于测量抗体反应的间接血凝试验(IHA)。结果表明,作为抗体反应的一种测量方法,放射性抗原结合试验优于IHA试验。C群脑膜炎球菌疫苗以粉末形式在4℃储存时高度稳定。迄今为止测试的所有批次的C群疫苗效力相同,分子量在520,000至2,000,000之间。已发现A群多糖在4℃储存2年后不稳定。对A群疫苗的最佳抗体反应似乎与制剂的分子大小直接相关。