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

• Published in: BMC medicine 2021-07, Vol.19 (1), p.1-148, Article 148
• Main Authors: 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
• Format: Article
• Language: English
• Subjects: Adverse events; Age; Antibodies; Antigens; Birth weight; Chronic infection; Chronology; Cohort analysis; Cooperation; Deoxyribonucleic acid; Disease transmission; DNA; Dosage; Dosage and administration; Drug dosages; Failure analysis; Failure rates; Health aspects; Hepatitis; Hepatitis B; Hepatitis B surface antigen; Hepatitis B vaccine; High dose; Immune response; Immune system; Immunoassay; Immunoprophylaxis; Infants; Infants (Newborn); Infections; Kinases; Laboratories; Mother-to-child transmission; Mothers; Patients; Pediatric research; Pediatrics; Perinatal infection; Prevention; Risk factors; Safety; Vaccines; Viruses
• ISSN: 1741-7015; 1741-7015
• DOI: 10.1186/s12916-021-02025-1

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 [mu]g or 20 [mu]g 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 [mu]g 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 [mu]g group were not significantly different from the 10 [mu]g 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 [greater than or equai to] 1000 IU/L) (P < 0.0001) in infants born to mothers with HBV DNA < 5 log.sub.10 IU/mL. For infants born to mothers with HBV DNA [greater than or equai to] 5 log.sub.10 IU/mL, 20 [mu]g HB vaccine did not present these above response advantages. The 20 [mu]g HB vaccine showed good safety for infants. Conclusions The 20 [mu]g 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.sub.10 IU/mL. Trial registration Chinese Clinical Trial Registry, ChiCTR-PRC-09000459 Keywords: Hepatitis B vaccine, High dose, Mother-to-child transmission, Immune response