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在北卡罗来纳州梅克伦堡县进行的b型流感嗜血杆菌和C群脑膜炎奈瑟菌荚膜多糖免疫接种对照现场试验的中期报告(1974年3月 - 1976年3月)

Interim report of a controlled field trial of immunization with capsular polysaccharides of Haemophilus influenzae type b and group C Neisseria meningitidis in Mecklenburg county, North Carolina (March 1974-March 1976).

作者信息

Parke J C, Schneerson R, Robbins J B, Schlesselman J J

出版信息

J Infect Dis. 1977 Aug;136 Suppl:S51-6. doi: 10.1093/infdis/136.supplement.s51.

Abstract

Approximately 16,000 children, from two months to five years of age, were vaccinated with the capsular polysaccharide of either Haemophilus influenzae type b or group C Neisseria meningitidis. Immunizations were carried out in a double-masked, randomized manner; the doses of immunogens used were 10 microgram of H. influenzae type b polysaccharide and 25 micron g of the group CN. meningitidis polysaccharide. Immunogenicity of the two vaccines was measured in single, random specimens of blood taken from vaccinees of all ages at various intervals after immunization. A positive effect on formation of serum antibody was observed in children of all ages vaccinated with N. meningitidis polysaccharide, but increased levels of serum antibody to H. influenzae type b were observed only in recipients of that vaccine who were three years of age or older. No untoward reactions to either vaccine were noted, and both vaccines retained their original molecular size after storage for three years. Too few cases of disease have been studied for a definitive assessment of vaccine efficacy; however, a slightly protective effect against meningitis was observed for the H. influenzae type b vaccine in infants up to one year of age.

摘要

约16000名两个月至五岁的儿童接种了b型流感嗜血杆菌或C群脑膜炎奈瑟菌的荚膜多糖疫苗。免疫接种以双盲、随机的方式进行;使用的免疫原剂量分别为10微克b型流感嗜血杆菌多糖和25微克C群脑膜炎奈瑟菌多糖。在免疫接种后的不同时间间隔,从各年龄段的受种者中随机抽取单份血样,检测这两种疫苗的免疫原性。接种脑膜炎奈瑟菌多糖疫苗的各年龄段儿童均观察到对血清抗体形成有积极作用,但仅在三岁及以上接种该疫苗的受种者中观察到b型流感嗜血杆菌血清抗体水平升高。未观察到两种疫苗有任何不良反应,且两种疫苗在储存三年后均保持其原始分子大小。因研究的疾病病例过少,无法对疫苗效力进行明确评估;然而,在一岁以下婴儿中观察到b型流感嗜血杆菌疫苗对脑膜炎有轻微保护作用。

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