Xiaohui Zhang1,2, Huaibin Zou1,2, Yu Chen1,2, Hua Zhang3, Ruihua Tian3, Jun Meng3, Yunxia Zhu3, Huimin Guo1, Erhei Dai4, Baoshen Zhu4, Zhongsheng Liu5, Yanxia Jin5, Yujie Li6, Liping Feng6, Hui Zhuang7, Calvin Q Pan8, Jie Li9, Zhongping Duan10,11. 1. Artificial Liver Treatment Center, Beijing Youan Hospital, Capital Medical University, Beijing, China. 2. Beijing Municipal Key Laboratory of Liver Failure and Artificial Liver Treatment Research, Beijing, China. 3. Department of Obstetrics and Gynecology, Beijing Youan Hospital, Capital Medical University, Beijing, China. 4. Department of Liver Diseases, The Fifth Hospital of Shijiazhuang, Shijiazhuang, China. 5. Tongliao Infective Disease Hospital, Tongliao, China. 6. Department of Obstetrics and Gynecology, Taiyuan No. 3 Hospital, Taiyuan, China. 7. Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China. 8. Division of Gastroenterology and Hepatology, Department of Medicine, New York University, Langone Health, NYU Grossman School of Medicine, New York, USA. panc01@nyu.edu. 9. Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China. jieli69@263.net. 10. Artificial Liver Treatment Center, Beijing Youan Hospital, Capital Medical University, Beijing, China. duan@ccmu.edu.cn. 11. Beijing Municipal Key Laboratory of Liver Failure and Artificial Liver Treatment Research, Beijing, China. duan@ccmu.edu.cn.
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.
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.
Authors: M Chiaramonte; S Majori; T Ngatchu; M E Moschen; V Baldo; G Renzulli; I Simoncello; S Rocco; T Bertin; R Naccarato; R Trivello Journal: Vaccine Date: 1996-02 Impact factor: 3.641