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Abstract：
BACKGROUND: In endemic areas, vertical transmission of hepatitis B virus (HBV) remains a major source of the global reservoir of infected people. Eliminating mother-to-child transmission (MTCT) of HBV is at the heart of World Health Organization\'s goal of reducing the incidence of HBV in children to less than 0.1% by 2030. Universal screening for hepatitis B during pregnancy and neonatal vaccination are the main preventive measures.
OBJECTIVE: To evaluate the efficacy of HBV vaccination combined with one dose of immunoglobulin in children born to hepatitis B surface antigen (HBsAg)-positive mothers in Djibouti city.
METHODS: We conducted a study in a prospective cohort of HBsAg-positive pregnant women and their infants. The study ran from January 2021 to May 2022, and infants were followed up to 7 mo of age. HBV serological markers and viral load in pregnant women were measured using aVidas microparticle enzyme-linked immunosorbent assay (Biomérieux, Paris, France) and the automated Amplix platform (Biosynex, Strasbourg, France). All infants received hepatitis B immunoglobulin and were vaccinated against HBV at birth. These infants were closely monitored to assess their seroprotective response and for failure of immunoprophylaxis. Simple logistic regression was also used to identify risk factors associated with immunoprophylaxis failure and poor vaccine response. All statistical analyses were performed with version 4.0.1 of the R software.
RESULTS: Of the 50 pregnant women recruited, the median age was 31 years, ranging from 18 years to 41 years. The MTCT rate in this cohort was 4% (2/50) in HBsAg-positive women and 67% (2/3) in hepatitis B e antigen-positive women with a viral load > 200000 IU/mL. Of the 48 infants who did not fail immunoprophylaxis, 8 (16%) became poor responders (anti-HB < 100 mIU/mL) after HBV vaccination and hepatitis B immunoglobulin, while 40 (84%) infants achieved a good level of seroprotection (anti-HB > 100 mIU/mL). Factors associated with this failure of immunoprophylaxis were maternal HBV DNA levels (> 200000 IU/mL) and hepatitis B e antigen-positive status (odds ratio = 158, 95% confidence interval: 5.05-4958, P < 0.01). Birth weight < 2500 g was associated with a poor immune response to vaccination (odds ratio = 34, 95% confidence interval: 3.01-383.86, P < 0.01).
CONCLUSIONS: Despite a failure rate of immunoprophylaxis higher than the World Health Organization target, this study showed that the combination of immunoglobulin and HBV vaccine was effective in preventing MTCT of HBV. Therefore, further studies are needed to better understand the challenges associated with immunoprophylaxis failure in infants in Djibouti city.
OBJECTIVE: To evaluate the efficacy of HBV vaccination combined with one dose of immunoglobulin in children born to hepatitis B surface antigen (HBsAg)-positive mothers in Djibouti city.
METHODS: We conducted a study in a prospective cohort of HBsAg-positive pregnant women and their infants. The study ran from January 2021 to May 2022, and infants were followed up to 7 mo of age. HBV serological markers and viral load in pregnant women were measured using aVidas microparticle enzyme-linked immunosorbent assay (Biomérieux, Paris, France) and the automated Amplix platform (Biosynex, Strasbourg, France). All infants received hepatitis B immunoglobulin and were vaccinated against HBV at birth. These infants were closely monitored to assess their seroprotective response and for failure of immunoprophylaxis. Simple logistic regression was also used to identify risk factors associated with immunoprophylaxis failure and poor vaccine response. All statistical analyses were performed with version 4.0.1 of the R software.
RESULTS: Of the 50 pregnant women recruited, the median age was 31 years, ranging from 18 years to 41 years. The MTCT rate in this cohort was 4% (2/50) in HBsAg-positive women and 67% (2/3) in hepatitis B e antigen-positive women with a viral load > 200000 IU/mL. Of the 48 infants who did not fail immunoprophylaxis, 8 (16%) became poor responders (anti-HB < 100 mIU/mL) after HBV vaccination and hepatitis B immunoglobulin, while 40 (84%) infants achieved a good level of seroprotection (anti-HB > 100 mIU/mL). Factors associated with this failure of immunoprophylaxis were maternal HBV DNA levels (> 200000 IU/mL) and hepatitis B e antigen-positive status (odds ratio = 158, 95% confidence interval: 5.05-4958, P < 0.01). Birth weight < 2500 g was associated with a poor immune response to vaccination (odds ratio = 34, 95% confidence interval: 3.01-383.86, P < 0.01).
CONCLUSIONS: Despite a failure rate of immunoprophylaxis higher than the World Health Organization target, this study showed that the combination of immunoglobulin and HBV vaccine was effective in preventing MTCT of HBV. Therefore, further studies are needed to better understand the challenges associated with immunoprophylaxis failure in infants in Djibouti city.
摘要：
背景：在流行地区，乙型肝炎病毒（HBV）的垂直传播仍然是全球感染者的主要来源。消除HBV母婴传播（MTCT）是世界卫生组织到2030年将儿童HBV发病率降低到0.1％以下的目标的核心。妊娠期乙型肝炎的普遍筛查和新生儿疫苗接种是主要的预防措施。
目的：评估吉布提市乙型肝炎表面抗原（HBsAg）阳性母亲所生儿童的HBV疫苗联合一剂免疫球蛋白的疗效。
方法：我们在HBsAg阳性孕妇及其婴儿的前瞻性队列中进行了一项研究。该研究从2021年1月到2022年5月进行，婴儿被随访到7个月。使用aVidas微粒酶联免疫吸附测定（Biomeerieux，巴黎,法国）和自动化的Amplix平台（Biosynex，斯特拉斯堡,法国)。所有婴儿都接受了乙型肝炎免疫球蛋白，并在出生时接种了HBV疫苗。密切监测这些婴儿，以评估其血清保护反应和免疫预防失败。简单逻辑回归也用于确定与免疫预防失败和疫苗应答不良相关的危险因素。所有统计分析均使用R软件4.0.1版进行。
结果：在招募的50名孕妇中，中位年龄为31岁,从18年到41年不等。在这个队列中的MTCT率是4％（2/50）在HBsAg阳性妇女和67％（2/3）在乙型肝炎e抗原阳性妇女与病毒载量>200000IU/mL。在48名没有免疫失败的婴儿中，8（16％）成为不良反应者（抗HB<100mIU/mL）后，乙肝疫苗接种和乙型肝炎免疫球蛋白，而40（84％）婴儿达到了良好的血清保护水平（抗HB>100mIU/mL）。与这种免疫预防失败相关的因素是母体HBVDNA水平（>200000IU/mL）和乙型肝炎e抗原阳性状态（比值比=158，95％置信区间：5.05-4958，P<0.01）。出生体重<2500g与疫苗接种的免疫应答差相关(比值比=34,95%置信区间:3.01-383.86,P<0.01)。
结论：尽管免疫预防的失败率高于世界卫生组织的目标，这项研究表明，免疫球蛋白和HBV疫苗的组合可以有效预防HBV的MTCT。因此,需要进一步的研究来更好地了解吉布提市与婴儿免疫预防失败相关的挑战.
目的：评估吉布提市乙型肝炎表面抗原（HBsAg）阳性母亲所生儿童的HBV疫苗联合一剂免疫球蛋白的疗效。
方法：我们在HBsAg阳性孕妇及其婴儿的前瞻性队列中进行了一项研究。该研究从2021年1月到2022年5月进行，婴儿被随访到7个月。使用aVidas微粒酶联免疫吸附测定（Biomeerieux，巴黎,法国）和自动化的Amplix平台（Biosynex，斯特拉斯堡,法国)。所有婴儿都接受了乙型肝炎免疫球蛋白，并在出生时接种了HBV疫苗。密切监测这些婴儿，以评估其血清保护反应和免疫预防失败。简单逻辑回归也用于确定与免疫预防失败和疫苗应答不良相关的危险因素。所有统计分析均使用R软件4.0.1版进行。
结果：在招募的50名孕妇中，中位年龄为31岁,从18年到41年不等。在这个队列中的MTCT率是4％（2/50）在HBsAg阳性妇女和67％（2/3）在乙型肝炎e抗原阳性妇女与病毒载量>200000IU/mL。在48名没有免疫失败的婴儿中，8（16％）成为不良反应者（抗HB<100mIU/mL）后，乙肝疫苗接种和乙型肝炎免疫球蛋白，而40（84％）婴儿达到了良好的血清保护水平（抗HB>100mIU/mL）。与这种免疫预防失败相关的因素是母体HBVDNA水平（>200000IU/mL）和乙型肝炎e抗原阳性状态（比值比=158，95％置信区间：5.05-4958，P<0.01）。出生体重<2500g与疫苗接种的免疫应答差相关(比值比=34,95%置信区间:3.01-383.86,P<0.01)。
结论：尽管免疫预防的失败率高于世界卫生组织的目标，这项研究表明，免疫球蛋白和HBV疫苗的组合可以有效预防HBV的MTCT。因此,需要进一步的研究来更好地了解吉布提市与婴儿免疫预防失败相关的挑战.
