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国产乙型肝炎疫苗不同剂量免疫效果的研究

TITERS AND PERSISTENCE OE ANTIBODIES FOLLOWING VACCINATION WITH DIFFERENT DOSES OF HEPATITIS B VACCINE IN CHILDREN

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【摘要】 本文报道应用上海生物制品研究所生产的乙型肝炎(血源)疫苗对上海、山东8~11岁的血清乙肝标志均阴性的学龄儿童,随机分至5μg、10μg和 20μg三组,按0、1、6月免疫程序接种,全程后 3月(即首针后 9月)三组的 Anti-HBs阳转率分别为 94.4%、99.1%和 90.4%。GMT(几何均数滴度)RIA S/N 在107.1~140.6之间;24月时阳转率仍在90.9~96.5%之间,S/N 在89.1~118.8之间。S/N≥10 者5μg、10μg和 20μg各为 90.0%、94.0%和 86.4%,无显著性差异。

【Abstract】 Children 8-11 year old were screened with RIA for markers of hepatitis B virus infection (HBsAg, Anti-HBs, Anti-HBc) and negative ones entered into the test program. They were randomly divided into three groups, receiving 5μg,10μg and 20μg hepatitis B vaccine recpectively for three doses at o, 1 and 6 months. Nine months after the first dose, antibody to hepatitis B surface antigen (Anti-HBs) was detected by radioimmunoassay. No difference in the three groups was observed on the serocon-version rate (Tab 1. p>0.05) . Twenty-four months after the start of the vaccination programme,over 90% of subjects remained positive for Anti-HBS. The geometric mean titer (GMT) in RIA S/N units were between. 94.2-121.5. In the three groups, those with GMT S/N≥10 were 90.0%, 94% and 86.4% respectvely. These results demonstrated that three doses of 5μg of hepatitis B vaccine were sufficient in children to obtain a high immunogenic effect.

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