Improved prevention of perinatal hepatitis B transmission HBV by employing the Bio-Hep-B PreS1/PreS2/S HBV vaccine in new born babies from HBV positive mothers

通过对 HBV 阳性母亲的新生儿使用 Bio-Hep-B PreS1/PreS2/S HBV 疫苗，改善围产期乙型肝炎传播 HBV 的预防

• 批准号: 82982556
• 负责人: Professor Dr. Dieter Glebe
• 金额: --
• 依托单位: Institut für Medizinische Virologie
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2009
• 资助国家: 德国
• 起止时间: 2008-12-31 至 2014-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/82982556?language=en
• 关键词: Improved; prevention; perinatal; hepatitis; transmission

As HBV prevalence is high in the Palestinian population with elevated mother to child transmission in spite of vaccination, we will perform the following: 1. Determine the prevalence of HBV infection in pregnant Palestinian women, by screening for anti-HBc antibodies, HBsAg and anti-HBs. 2. Characterise the state of HBV infection in HBsAg positive mothers (HBeAg and HBV DNA load). 3. In the newborn babies of HBsAg positive mothers, we will compare the efficacy of the conventional Engerix B vaccine that contains only the S-HBsAg protein with an alternative licensed PreS1, PreS2, S-containing vaccine (Bio-Hep-B that includes all three HBsAg proteins). 4. Determine the failure rate of vaccination in this particular setting by following the vaccinated children for at least one year. They will be tested for HBsAg, HBV DNA, anti-HBc, anti-HBs and if positive for anti-HBc for further HBV markers. 5. Investigate the major reason for vaccination failures: is it related to a breakthrough of wild type HBV or escape mutants? For this purpose we will employ molecular biology tools to amplify and sequence the preS/S gene region of all HBV DNA positive mothers and infants. The genotyping data will be analysed and compared to known genotypes. The neutralising potential of vaccine-induced antibodies against HBV escape mutants shall be studied in vitro. 6. A final recommendation based on this research data should be a reference for the Palestinian health institution to consider the optimisation of the vaccination program and the type of vaccine to be used.

由于HBV在巴勒斯坦人群中的流行率很高，尽管接种了疫苗，但母婴传播率仍很高，我们将执行以下操作：1.通过筛查抗-HBc抗体、HBsAg和抗-HBs，确定巴勒斯坦孕妇HBV感染的流行率。 2.描述HBsAg阳性母亲的HBV感染状态（HBeAg和HBV DNA载量）。 3.在HBsAg阳性母亲的新生儿中，我们将比较仅含S-HBsAg蛋白的传统Engerix B疫苗与另一种已获许可的含PreS 1、PreS 2和S的疫苗（包括所有三种HBsAg蛋白的Bio-Hep-B）的有效性。 4.通过对接种疫苗的儿童进行至少一年的随访，确定在这种特殊情况下的疫苗接种失败率。他们将接受HBsAg、HBV DNA、抗-HBc、抗-HBs检测，如果抗-HBc阳性，则接受进一步的HBV标志物检测。 5.调查疫苗接种失败的主要原因：是否与野生型HBV或逃逸突变株的突破有关？为此，我们将采用分子生物学工具扩增和测序所有HBV DNA阳性的母亲和婴儿的preS/S基因区。将分析基因分型数据并与已知基因型进行比较。应在体外研究疫苗诱导的抗HBV逃逸突变体抗体的中和潜力。 6.根据这一研究数据提出的最后建议应作为巴勒斯坦卫生机构考虑优化疫苗接种计划和使用的疫苗类型的参考。