Low-dose intradermal versus intramuscular administration of recombinant hepatitis B vaccine:: a comparison of immunogenicity in infants and preschool children
Low-dose intradermal versus intramuscular administration of recombinant hepatitis B vaccine:: a comparison of immunogenicity in infants and preschool children
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DOI：
10.1016/s0264-410x(98)80006-6
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发表时间：
1998-10-01
期刊：
影响因子：
5.5
通讯作者：
Akilli, M
中科院分区：
文献类型：
--
作者：
Egemen, A;Aksit, S;Akilli, M
200名婴儿和200名学龄前儿童被随机分配在0、1和6个月时接受10 μ g重组乙型肝炎疫苗（GenHevac B）肌肉注射（IM）或2 μ g三角肌皮下注射（ID）。第三次接种后8周检测乙型肝炎表面抗原抗体（anti-HBs）。重组乙肝疫苗的标准剂量IM和低剂量ID产生的抗- hbs率等于或高于20 mIU ml（-1）的婴儿（分别为98%和94%）和学龄前儿童（分别为98%和100%）相当。尽管IM疫苗在婴儿（几何平均滴度-GMT， 935对621 mIU ml(-1)）和学龄前儿童（GMT 1393对804 mIU ml(-1)）中产生的抗hbs浓度高于ID疫苗，但差异无统计学意义（p > 0.05）。学龄前儿童的抗hbs浓度高于婴儿。两组疫苗均未见临床严重不良反应；然而，注射部位的硬结和色素沉着在皮内接种疫苗的研究人群中更为常见。我们的结论是，在婴儿和学龄前儿童中皮内注射2 μ g重组乙型肝炎疫苗是安全有效的，并且可能是一种可接受的、更便宜的大规模免疫接种替代全剂量IM疫苗的方法，特别是在发展中国家。1998爱思唯尔科学有限公司版权所有。
Two hundred infants and two hundred preschool children were randomly assigned to receive either 10 mu g of recombinant hepatitis B vaccine (GenHevac B) intramuscular ly (IM) or 2 mu g intradermally (ID) in the deltoid region at 0, 1 and 6 months. Antibody to hepatitis B surface antigen (anti-HBs) was tested eight weeks after the third vaccine dose. Standard dose IM and low-dose ID administration of recombinant hepatitis B vaccine produced comparable rates df anti-HBs equal to or higher than 20 mIU ml(-1) infants (98% and 94%, respectively) and preschool children (98% and 100%, respectively). Although IM vaccination produced higher anti-HBs concentrations than ID vaccination both in infants (geometric mean titre-GMT, 935 versus 621 mIU ml(-1)) and preschool children (GMT 1393 versus 804 mIU ml(-1)), the differences were not statistically significant (p > 0.05). The preschool children tended to have higher anti-HBs concentrations than the infants. No clinically serious adverse effects were observed in both vaccine groups; however induration and hyperpigmentation at the injection site were more often seen in the study population that was vaccinated intradermally. We conclude that intradermal administration of 2 mu g recombinant hepatitis B vaccine is safe and effective in infants and preschool children, and may be an acceptable, less expensive alternative to full-dose IM vaccination for mass immunization, especially in developing countries. (C) 1998 Elsevier Science Ltd. All rights reserved.