Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2021 Jul 13;19(1):148.
doi: 10.1186/s12916-021-02025-1.

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

Xiaohui Zhang #  1   2 , Huaibin Zou #  1   2 , Yu Chen  1   2 , Hua Zhang  3 , Ruihua Tian  3 , Jun Meng  3 , Yunxia Zhu  3 , Huimin Guo  1 , Erhei Dai  4 , Baoshen Zhu  4 , Zhongsheng Liu  5 , Yanxia Jin  5 , Yujie Li  6 , Liping Feng  6 , Hui Zhuang  7 , Calvin Q Pan  8 , Jie Li  9 , Zhongping Duan  10   11
Affiliations
Multicenter Study

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

Xiaohui Zhang et al. BMC Med. .

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.

Keywords: Hepatitis B vaccine; High dose; Immune response; Mother-to-child transmission.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
The flow chart of subject recruitment for this study. Abbreviation: HBsAg, hepatitis B surface antigen
See this image and copyright information in PMC

References

    1. Hepatitis B. World Health Organization Fact Sheets. https://www.who.int/news-room/fact-sheets/detail/hepatitis-b. Accessed 1 May 2020.
    1. Liu J, Liang W, Jing W, Liu M. Countdown to 2030: eliminating hepatitis B disease, China. Bull World Health Organ. 2019;97(3):230–238. doi: 10.2471/BLT.18.219469. - DOI - PMC - PubMed
    1. Ma L, Alla NR, Li X, Mynbaev OA, Shi Z. Mother-to-child transmission of HBV: review of current clinical management and prevention strategies. Rev Med Virol. 2014;24(6):396–406. doi: 10.1002/rmv.1801. - DOI - PubMed
    1. Park JS, Pan CQ. Viral factors for HBV mother-to-child transmission. Hepatol Int. 2017;11(6):476–480. doi: 10.1007/s12072-017-9825-y. - DOI - PubMed
    1. Zhao M, Zou H, Chen Y, Zheng S, Duan Z. Efficacy of antepartum administration of hepatitis B immunoglobulin in preventing mother-to-child transmission of hepatitis B virus. J Viral Hepat. 2019;26(9):1059–1065. doi: 10.1111/jvh.13123. - DOI - PMC - PubMed

Publication types

Substances