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Low-dose intradermal administration of recombinant hepatitis B vaccine in children: 5-year follow-up study

机译：儿童低剂量皮内注射重组乙型肝炎疫苗：5年随访研究

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Several studies have documented the efficacy of low-dose intradermal administration of hepatitis B vaccine. However, little is known about the duration of protection provided by low-dose intradermal administration of hepatitis B vaccine. This study reports results from a 5-year follow up period of 200 healthy children (100 infants and 100 preschool children) immunized intradermally with 2 mug doses of recombinant hepatitis B vaccine (GenHevac B) at months 0,1, and 6. In the 8th week after the third vaccine dose, 97% of the children developed anti-HBs antibodies higher than or equal to 10 mlU ml(-1), and the antiHBs geometric mean titre (GMT) was 676 mlU ml(-1). In month 18 and year 5, the anti-HBs GMT decreased to approximately one-third (220 mlU ml(-1)) and one-tenth (68 mlU ml(-1)) of the initial levels, respectively. However, 87% of the children had protective levels of anti-HBs ( greater than or equal to 10 mlU ml(-1)) after 5 years. Among 156 children followed for 5 years, none became positive for anti-HBc and/or HbsAg. Seven children who were seronegative after 5 years developed anti-HBs antibodies higher than 1000 mlU ml(-1) after an additional 10 mug intramuscular hepatitis B vaccine. Persistent immunologic memory over periods of 5 years or more is evident, the anamnestic antibody response to a booster dose of vaccine, even in these children who have lost antibody. We conclude that intradermal administration of 2 mug recombinant hepatitis B vaccine provides long-term protection against hepatitis B virus in infants and preschool children.
机译：多项研究已证明低剂量皮内注射乙型肝炎疫苗的功效。但是，对于由低剂量的皮内注射乙型肝炎疫苗提供的保护期知之甚少。这项研究报告了对200名健康儿童（100名婴儿和100名学龄前儿童）进行5年随访的结果，分别在第0.1和第6个月用2杯剂量的重组乙型肝炎疫苗（GenHevac B）进行了皮内免疫。第三次疫苗接种后第8周，有97％的儿童产生了高于或等于10 mlU ml（-1）的抗HBs抗体，抗HBs几何平均滴度（GMT）为676 mlU ml（-1）。在第18个月和第5年，抗HBs GMT分别降至初始水平的约三分之一（220 mlU ml（-1））和十分之一（68 mlU ml（-1））。但是，有87％的儿童在5年后具有抗HBs保护水平（大于或等于10 mlU ml（-1））。在随访了5年的156名儿童中，没有一个人的抗HBc和/或HbsAg阳性。在另外5杯10杯肌内注射乙型肝炎疫苗后，有7位5年后血清阴性的儿童产生了超过1000 mlU ml（-1）的抗HBs抗体。超过5年或更长时间的持久性免疫记忆是显而易见的，即使在这些抗体丢失的儿童中，记忆增强的抗体也会对加强剂量的疫苗产生反应。我们得出的结论是，皮下注射2杯重组乙型肝炎疫苗可为婴儿和学龄前儿童提供针对乙型肝炎病毒的长期保护。

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