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Immunogenicity and reactogenicity of a recombinant hepatitis B vaccine in subjects over age of forty years and response of a booster dose among nonresponders

机译:重组乙型肝炎疫苗在40岁以上受试者中的免疫原性和反应原性以及无反应者中加强剂量的反应

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AIM: The study was initiated to evaluate the reactogenicity and immunogenicity of a recombinant hepatitis B vaccine in age group >40 years and to study the response of a single booster dose in primary non-responders to the hepatitis B vaccination. METHODS: A total of 102 volunteers without markers of hepatitis B infection (negative for HBsAg, anti-HBc antibody, HBeAg and anti-HBs antibody) received 20 μg of recombinant HB vaccine intramuscularly at 0, 1, and 6 months. Anti HBs titers were evaluated by a quantitative Elisa kit at 90 and 210 days. A booster dose of 20 g HB vaccine was given after 6 months of the 3rd vaccine dose to the 15 nonresponders and anti-HBs titers were measured after 1 month. RESULTS: Seroprotection (anti-HBs GMT~3 10 IU/L) was achieved in 85.3 % (87/102) volunteers. The mean GMT titers of the vaccine responders was 136.1 IU/L. Of the seroprotected individuals, there were 32.4 % (33/102) hyporesponders (anti-HBs titers < 10-99 mlU/ml) and 52.9 % (54/102) were responders (anti-HBs titers > 100 IU/L). All the non-responders (15/15) responded to a single dose of the booster dose of recombinant HB vaccine and their mean anti-HBs antibody titers were more than 100.5 mIU/ml after the booster dose. CONCLUSION: Recombinant hepatitis B vaccine offers good seroprotection in the age group >40 years and has a good safety profile. A single booster dose after 6 months in primary non-responders leads to good seroprotective anti-HBs antibody titers. However, larger population based studies are needed to evaluate the role of a booster dose in selected group of non-responders and whether such an approach will be cost effective.
机译:目的:该研究旨在评估年龄> 40岁的重组乙型肝炎疫苗的反应原性和免疫原性,并研究初次无反应者中单次加强剂量对乙型肝炎疫苗接种的反应。方法:共有102名无乙型肝炎感染标志物(HBsAg,抗HBc抗体,HBeAg和抗HBs抗体阴性)的志愿者在0、1、6个月时肌肉注射了20μg重组HB疫苗。在90天和210天通过定量Elisa试剂盒评估抗HBs滴度。在第三剂疫苗的6个月后,对15名无反应者给予20 g HB疫苗的加强剂量,并在1个月后测量抗HBs滴度。结果:85.3%(87/102)的志愿者达到了血清保护(抗HBs GMT〜3 10 IU / L)。疫苗应答者的平均GMT滴度为136.1 IU / L。在血清保护的个体中,有32.4%(33/102)的低反应者(抗HBs滴度<10-99 mlU / ml)和52.9%(54/102)的反应者(抗HBs滴度> 100 IU / L)。所有无反应者(15/15)对加强剂量的重组HB疫苗的单剂量反应,在加强剂量后,它们的平均抗HBs抗体滴度超过100.5 mIU / ml。结论:重组乙型肝炎疫苗在> 40岁年龄组中具有良好的血清保护作用,并且具有良好的安全性。在原发性无反应者中,六个月后单次加强剂量可产生良好的血清保护性抗HBs抗体滴度。但是,需要进行更多的基于人群的研究,以评估加强剂量在选定的无反应者组中的作用,以及这种方法是否具有成本效益。

著录项

  • 来源
    《World Journal of Gastroenterology》 |2003年第5期|p.1132-1134|共3页
  • 作者单位

    Department of Medicine, Maulana Azad Medical College & L. N. Hospital, New Delhi. Medical Advisor, Panacea Biotec Co., New Delhi;

  • 收录信息 美国《科学引文索引》(SCI);美国《工程索引》(EI);美国《生物学医学文摘》(MEDLINE);美国《化学文摘》(CA);
  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 消化系及腹部疾病;
  • 关键词

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