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评估2月龄儿童开始接种甲型肝炎灭活疫苗的免疫原性和安全性的临床试验。

Clinical trial to evaluate immunogenicity and safety of inactivated hepatitis A vaccination starting at 2-month-old children.

作者信息

Kanra G, Yalçin S S, Ceyhan M, Yurdakök K

机构信息

Department of Pediatrics, Faculty of Medicine, Hacettepe University, Ankara, Turkey.

出版信息

Turk J Pediatr. 2000 Apr-Jun;42(2):105-8.

PMID:10936974
Abstract

Active immunization with hepatitis A vaccine has been shown to provide long-term protection against hepatitis A virus (HAV) infection. However, few data are available regarding use of the hepatitis A vaccine in children under two years of age. The present study was conducted to test the safety and immunogenicity of inactivated hepatitis A vaccine administered to infants, and to evaluate the correlation between mother and infant anti-HAV antibodies. A total of sixty healthy children, two months of age, were enrolled in this study and immunized with 360 EU of inactivated hepatitis A vaccine (Havrix) according to the two, four and six months of age schedule. Blood sampling was performed prior to the first vaccination and one month after the third vaccination at seven months. Venipuncture was also done on mother on admission. The reactogenicity was expressed as the percentage of reported local and systemic reactions. The most common side effects were erythema on the injection site and fever. Infants with passively transferred maternal anti-HAV antibodies had a reduced anti-HAV GMT after vaccination. On admission, only one infant and his mother were seronegative and seroconversion was only detected in this infant. One month after the third dose seven infants (12.3%) were found to be seronegative. The infant without passively acquired maternal anti-HAV had the protective levels with a GMT of 3176 mIU/ml one month following the third dose. There was a significant positive correlation between the titers of mother and infant anti-HAV antibodies (n = 0.96, p < 0.001) on admission. Hepatitis A vaccine showed no immunogenicity in infants with presence of maternal antibodies. Hepatitis A vaccine is safe but it should be used after the disappearance of maternal antibodies.

摘要

甲型肝炎疫苗主动免疫已被证明可提供针对甲型肝炎病毒(HAV)感染的长期保护。然而,关于两岁以下儿童使用甲型肝炎疫苗的数据很少。本研究旨在测试给予婴儿的灭活甲型肝炎疫苗的安全性和免疫原性,并评估母婴抗-HAV抗体之间的相关性。共有60名两个月大的健康儿童参与本研究,并按照2、4和6月龄的接种程序接种360 EU的灭活甲型肝炎疫苗(Havrix)。在首次接种前以及七个月时第三次接种后一个月进行血液采样。母亲入院时也进行静脉穿刺。反应原性以报告的局部和全身反应的百分比表示。最常见的副作用是注射部位红斑和发热。具有被动转移的母体抗-HAV抗体的婴儿接种疫苗后抗-HAV GMT降低。入院时,只有一名婴儿及其母亲血清学阴性,仅在该婴儿中检测到血清转化。第三次接种后一个月,发现七名婴儿(12.3%)血清学阴性。未被动获得母体抗-HAV的婴儿在第三次接种后一个月抗-HAV GMT为3176 mIU/ml,达到保护水平。入院时母婴抗-HAV抗体滴度之间存在显著正相关(n = 0.96,p < 0.001)。在存在母体抗体的婴儿中,甲型肝炎疫苗显示无免疫原性。甲型肝炎疫苗是安全的,但应在母体抗体消失后使用。

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