title: Hepatitis B vaccine alone may be enough for preventing hepatitis B virus transmission in neonates of HBsAg (+)/HBeAg (-) mothers.
abstract: To prospectively evaluate the efficacy of vaccine alone compared with vaccine plus HBIG for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (-) mothers.
  
  
  
  Combined immunization is currently recommended for neonates of HBsAg (+) mothers in China. As a result, a randomized design is infeasible due to ethical reasons. In practice, Guangxi Zhuang Autonomous Region and Jiangsu Province implement vaccine alone and vaccine plus HBIG strategies for neonates born to HBsAg (+)/HBeAg (-) mothers, respectively. We alternatively enrolled neonates of HBsAg (+)/HBeAg (-) mothers from these two regions. Three doses of a recombinant yeast-derived hepatitis B vaccine were given at 0, 1 and 6months with or without HBIG at birth.
  
  
  
  At 7months, sera were collected from 132 neonates in Guangxi Zhuang Autonomous Region and 752 neonates in Jiangsu Province. Baseline characteristics of both mothers and neonates were comparable in the two regions. No differences were revealed regarding the occurrence of perinatal HBV transmission with or without HBIG at birth [0.1% (1/752) vs. 0.0% (0/132), p=1.000]. The anti-HBs response rates were 97.7% (129/132) and 98.5% (740/751) for the neonates with vaccine alone and with HBIG (p=0.758), respectively. Vaccine alone induced a significantly higher anti-HBs GMC as compared to vaccine plus HBIG at 7months of age (1555.3mIU/mL vs. 654.9mIU/mL, p<0.0001). At 12months of age, protective levels of anti-HBs remained in 97.4% (596/612) and 98.3% (118/120) of the neonates receiving and not receiving HBIG, respectively (p=0.771). The neonates receiving combined prophylaxis had a markedly lower anti-HBs GMC (210.7mIU/mL vs. 297.0mIU/mL, p=0.011). Horizontal HBV transmission occurred in none of the successfully immunized neonates for both compared groups at 12months of age.
  
  
  
  Vaccine alone may be enough for preventing HBV transmission in neonates of HBsAg (+)/HBeAg (-) mothers.
authors.affiliation: Department of Microbiology and Center of Infectious Diseases, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China.
authors.forename: Ying
authors.initials: Y
authors.lastname: Lu
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Xiao-Feng
authors.initials: XF
authors.lastname: Liang
authors.affiliation: Chinese Center for Disease Control and Prevention, Beijing 102206, China.
authors.forename: Fu-Zhen
authors.initials: FZ
authors.lastname: Wang
authors.affiliation: Department of Microbiology and Center of Infectious Diseases, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Yan
authors.affiliation: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning 530028, China.
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.affiliation: Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention, Nanning 530028, China.
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.affiliation: Department of Infectious Disease, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
authors.affiliation: Department of Infectious Disease, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China.
authors.forename: Xiang-Jun
authors.initials: XJ
authors.lastname: Zhai
authors.affiliation: Department of Microbiology and Center of Infectious Diseases, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: jieli@bjmu.edu.cn.
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Microbiology and Center of Infectious Diseases, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China. Electronic address: zhuangbmu@126.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhuang
mesh_terms: D000293:Adolescent; D000328:Adult; D002681:China; D005260:Female; D006509:Hepatitis B / Q000635:transmission*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000235:genetics; D006513:Hepatitis B e Antigens / Q000097:blood*; D006801:Humans; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008297:Male; D011247:Pregnancy; D011446:Prospective Studies; D016896:Treatment Outcome; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000235:genetics; D055815:Young Adult
chemical_list: D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D006513:Hepatitis B e Antigens; D016756:Immunoglobulins, Intravenous; D014614:Vaccines, Synthetic
keywords: Hepatitis B immunoglobulin; Hepatitis B vaccine; Hepatitis B virus; Hepatitis B virus e antigen; Hepatitis B virus surface antigen; Mother-to-child transmission