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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

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 vacc...

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Autores principales: Zhang, Xiaohui, Zou, Huaibin, Chen, Yu, Zhang, Hua, Tian, Ruihua, Meng, Jun, Zhu, Yunxia, Guo, Huimin, Dai, Erhei, Zhu, Baoshen, Liu, Zhongsheng, Jin, Yanxia, Li, Yujie, Feng, Liping, Zhuang, Hui, Pan, Calvin Q., Li, Jie, Duan, Zhongping
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276424/
https://www.ncbi.nlm.nih.gov/pubmed/34253217
http://dx.doi.org/10.1186/s12916-021-02025-1
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author Zhang, Xiaohui
Zou, Huaibin
Chen, Yu
Zhang, Hua
Tian, Ruihua
Meng, Jun
Zhu, Yunxia
Guo, Huimin
Dai, Erhei
Zhu, Baoshen
Liu, Zhongsheng
Jin, Yanxia
Li, Yujie
Feng, Liping
Zhuang, Hui
Pan, Calvin Q.
Li, Jie
Duan, Zhongping
author_facet Zhang, Xiaohui
Zou, Huaibin
Chen, Yu
Zhang, Hua
Tian, Ruihua
Meng, Jun
Zhu, Yunxia
Guo, Huimin
Dai, Erhei
Zhu, Baoshen
Liu, Zhongsheng
Jin, Yanxia
Li, Yujie
Feng, Liping
Zhuang, Hui
Pan, Calvin Q.
Li, Jie
Duan, Zhongping
author_sort Zhang, Xiaohui
collection PubMed
description 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 log(10) IU/mL. For infants born to mothers with HBV DNA ≥ 5 log(10) 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 log(10) IU/mL. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-PRC-09000459 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-021-02025-1.
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spelling pubmed-82764242021-07-13 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 Zhang, Xiaohui Zou, Huaibin Chen, Yu Zhang, Hua Tian, Ruihua Meng, Jun Zhu, Yunxia Guo, Huimin Dai, Erhei Zhu, Baoshen Liu, Zhongsheng Jin, Yanxia Li, Yujie Feng, Liping Zhuang, Hui Pan, Calvin Q. Li, Jie Duan, Zhongping BMC Med Research Article 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 log(10) IU/mL. For infants born to mothers with HBV DNA ≥ 5 log(10) 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 log(10) IU/mL. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-PRC-09000459 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s12916-021-02025-1. BioMed Central 2021-07-13 /pmc/articles/PMC8276424/ /pubmed/34253217 http://dx.doi.org/10.1186/s12916-021-02025-1 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research Article
Zhang, Xiaohui
Zou, Huaibin
Chen, Yu
Zhang, Hua
Tian, Ruihua
Meng, Jun
Zhu, Yunxia
Guo, Huimin
Dai, Erhei
Zhu, Baoshen
Liu, Zhongsheng
Jin, Yanxia
Li, Yujie
Feng, Liping
Zhuang, Hui
Pan, Calvin Q.
Li, Jie
Duan, Zhongping
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8276424/
https://www.ncbi.nlm.nih.gov/pubmed/34253217
http://dx.doi.org/10.1186/s12916-021-02025-1
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