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01-12-2021 | Hepatitis B | Research article

The effects of increased dose of hepatitis B vaccine on mother-to-child transmission and immune response for infants born to mothers with chronic hepatitis B infection: a prospective, multicenter, large-sample cohort study

Authors: Xiaohui Zhang, Huaibin Zou, Yu Chen, Hua Zhang, Ruihua Tian, Jun Meng, Yunxia Zhu, Huimin Guo, Erhei Dai, Baoshen Zhu, Zhongsheng Liu, Yanxia Jin, Yujie Li, Liping Feng, Hui Zhuang, Calvin Q. Pan, Jie Li, Zhongping Duan

Published in: BMC Medicine | Issue 1/2021

Abstract

Background

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.

Methods

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.

Results

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 log₁₀ IU/mL. For infants born to mothers with HBV DNA ≥ 5 log₁₀ IU/mL, 20 μg HB vaccine did not present these above response advantages. The 20 μg HB vaccine showed good safety for infants.

Conclusions

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 log₁₀ IU/mL.

Trial registration

Chinese Clinical Trial Registry, ChiCTR-PRC-09000459

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Title: The effects of increased dose of hepatitis B vaccine on mother-to-child transmission and immune response for infants born to mothers with chronic hepatitis B infection: a prospective, multicenter, large-sample cohort study
Authors: Xiaohui Zhang
Huaibin Zou
Yu Chen
Hua Zhang
Ruihua Tian
Jun Meng
Yunxia Zhu
Huimin Guo
Erhei Dai
Baoshen Zhu
Zhongsheng Liu
Yanxia Jin
Yujie Li
Liping Feng
Hui Zhuang
Calvin Q. Pan
Jie Li
Zhongping Duan
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Hepatitis B
Hepatitis B Vaccination
Published in: BMC Medicine / Issue 1/2021
Electronic ISSN: 1741-7015
DOI: https://doi.org/10.1186/s12916-021-02025-1

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The effects of increased dose of hepatitis B vaccine on mother-to-child transmission and immune response for infants born to mothers with chronic hepatitis B infection: a prospective, multicenter, large-sample cohort study

Abstract

Background

Methods

Results

Conclusions

Trial registration

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Trial registration

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