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冈比亚儿童皮内注射乙肝疫苗试验。

Trials of intradermal hepatitis B vaccines in Gambian children.

作者信息

Whittle H C, Lamb W H, Ryder R W

出版信息

Ann Trop Paediatr. 1987 Mar;7(1):6-9. doi: 10.1080/02724936.1987.11748464.

DOI:10.1080/02724936.1987.11748464
PMID:2439007
Abstract

Three trials of intradermal hepatitis B virus (HBV) vaccines were made in Gambian children. In the first trial HBV vaccine (1 microgram) was given to neonates in the same syringe with BCG followed by two further does of 1.0 microgram of intradermal HBV vaccine. The trial was a failure, for 19 of 32 subjects had an HBV surface antibody response of less than 10 m.i.u./ml. In the second trial in young children two different regimes were used: two doses of 2 micrograms HBV vaccine were given intradermally after a 20 micrograms intramuscular dose or three doses of 2 micrograms were given intradermally. In both cases geometric mean antibody responses were significantly lower than in the control group who were given 20 micrograms HBV intramuscularly followed by two 10 micrograms doses intramuscularly. Vaccine failures, defined as the presence of HBV surface antigen or core antibody or absence of surface antibody, were also significantly higher in the intradermal groups. In the third trial 4 micrograms of vaccine were given intradermally to 20 young children with a multiple orifice head fired by a jet gun: all had a good HBV surface antibody response of greater than 100 m.i.u./ml of serum.

摘要

在冈比亚儿童中进行了三项乙肝病毒(HBV)皮内疫苗试验。在第一项试验中,将HBV疫苗(1微克)与卡介苗用同一注射器给予新生儿,随后再接种两剂1.0微克的皮内HBV疫苗。该试验失败了,因为32名受试者中有19人的HBV表面抗体反应低于10 m.i.u./ml。在第二项针对幼儿的试验中,使用了两种不同的方案:在接种20微克肌肉注射剂量后皮内接种两剂2微克HBV疫苗,或皮内接种三剂2微克。在这两种情况下,几何平均抗体反应均显著低于对照组,对照组接受20微克肌肉注射HBV疫苗,随后再肌肉注射两剂10微克。皮内接种组中被定义为存在HBV表面抗原或核心抗体或不存在表面抗体的疫苗接种失败情况也显著更高。在第三项试验中,用喷枪向20名幼儿皮内接种4微克疫苗:所有人的血清HBV表面抗体反应良好,均大于100 m.i.u./ml。

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Trials of intradermal hepatitis B vaccines in Gambian children.冈比亚儿童皮内注射乙肝疫苗试验。
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