Back to Search Start Over

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

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 :
Hui Zhuang
Erhei Dai
Zhongsheng Liu
Calvin Q. Pan
Zhongping Duan
Jie Li
Jun Meng
Yujie Li
Huimin Guo
Yanxia Jin
Hua Zhang
Yu Chen
Liping Feng
Baoshen Zhu
Yunxia Zhu
Xiaohui Zhang
Ruihua Tian
Huaibin Zou
Source :
BMC Medicine, Vol 19, Iss 1, Pp 1-8 (2021), BMC Medicine
Publication Year :
2021
Publisher :
Springer Science and Business Media LLC, 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 10 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 10 IU/mL. Trial registration Chinese Clinical Trial Registry, ChiCTR-PRC-09000459

Details

ISSN :
17417015
Volume :
19
Database :
OpenAIRE
Journal :
BMC Medicine
Accession number :
edsair.doi.dedup.....4cf43538ec9e5f8dfd253379be0c3910
Full Text :
https://doi.org/10.1186/s12916-021-02025-1