Artificial Liver Treatment Center, Beijing Youan Hospital, Capital Medical University, Beijing, China.
Beijing Municipal Key Laboratory of Liver Failure and Artificial Liver Treatment Research, Beijing, China.
BMC Med. 2021 Jul 13;19(1):148. doi: 10.1186/s12916-021-02025-1.
Appropriate passive-active immunoprophylaxis effectively reduces mother-to-child transmission (MTCT) of hepatitis B virus (HBV), but the immunoprophylaxis failure was still more than 5% under the current strategy. The study objective was to investigate the effects of high dose of HB vaccine on MTCT and immune response for infants born to hepatitis B surface antigen (HBsAg)-positive mothers.
This was a prospective, multicenter, large-sample cohort study in four sites of China, and 955 pairs of HBsAg-positive mothers and their infants were enrolled in our investigation. The infants were given 10 μg or 20 μg HB vaccine (at age 0, 1, and 6 months) plus HB immunoglobulin (at age 0 and 1 month). Serum HBsAg, antibody to HBsAg (anti-HBs), and/or HBV DNA levels in the infants were determined at age 12 months. The safety of 20 μg HB vaccine was evaluated by adverse events and observing the growth indexes of infants.
Thirteen of 955 infants were HBsAg-positive at 12 months. Stratification analysis showed that immunoprophylaxis failure rates in the 20 μg group were not significantly different from the 10 μg group, whatever maternal HBV load was high or not. But the high dose of HB vaccine significantly reduced low-response rate (anti-HBs 10-100 IU/L) (P = 0.002) and middle-response rate (anti-HBs 100-1000 IU/L) (P = 0.022) and improved high-response rate (anti-HBs ≥ 1000 IU/L) (P < 0.0001) in infants born to mothers with HBV DNA < 5 log IU/mL. For infants born to mothers with HBV DNA ≥ 5 log IU/mL, 20 μg HB vaccine did not present these above response advantages. The 20 μg HB vaccine showed good safety for infants.
The 20 μg HB vaccine did not further reduce immunoprophylaxis failure of infants from HBsAg-positive mothers, but increased the high-response and decreased low-response rates for infants born to mothers with HBV DNA < 5 log IU/mL.
Chinese Clinical Trial Registry, ChiCTR-PRC-09000459.
适当的被动-主动免疫预防措施可有效降低乙型肝炎病毒（HBV）母婴传播（MTCT），但在目前的策略下，免疫预防失败率仍超过 5%。本研究的目的是探讨高剂量乙型肝炎疫苗对 HBsAg 阳性母亲所生婴儿 MTCT 和免疫应答的影响。
这是一项在中国四个地点进行的前瞻性、多中心、大样本队列研究，共纳入 955 对 HBsAg 阳性母亲及其婴儿。婴儿在 0、1 和 6 月龄时分别给予 10μg 或 20μg 乙型肝炎疫苗（HB 疫苗）（0、1 和 6 月龄），并在 0 和 1 月龄时分别给予乙型肝炎免疫球蛋白（HBIG）。在 12 月龄时检测婴儿的血清 HBsAg、抗-HBsAg（抗-HBs）和/或 HBV DNA 水平。通过不良事件和观察婴儿生长指标评估 20μg HB 疫苗的安全性。
955 例婴儿中有 13 例在 12 月龄时 HBsAg 阳性。分层分析显示，高病毒载量（HBV DNA≥5 log IU/mL）或低病毒载量（HBV DNA<5 log IU/mL）母亲所生婴儿中，20μg 组的免疫预防失败率与 10μg 组相比均无显著差异。但高剂量 HB 疫苗可显著降低低应答率（抗-HBs 10-100 IU/L）（P=0.002）和中应答率（抗-HBs 100-1000 IU/L）（P=0.022），提高高应答率（抗-HBs≥1000 IU/L）（P<0.0001）。对于 HBV DNA<5 log IU/mL 母亲所生婴儿，20μg HB 疫苗无上述应答优势。20μg HB 疫苗对婴儿具有良好的安全性。
20μg HB 疫苗并未进一步降低 HBsAg 阳性母亲所生婴儿的免疫预防失败率，但增加了 HBV DNA<5 log IU/mL 母亲所生婴儿的高应答率，降低了低应答率。
中国临床试验注册中心，ChiCTR-PRC-09000459。
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