title: Hepatitis B vaccine alone or with hepatitis B immunoglobulin in neonates of HBsAg+/HBeAg- mothers: a systematic review and meta-analysis.
abstract: OBJECTIVE
  The cost-effectiveness of augmenting immunization against hepatitis B infection with hepatitis B immunoglobulin (HBIG) remains controversial, particularly for the subpopulation of babies of HBsAg+/HBeAg- mothers that are considered as low-infective. We aimed to evaluate the effectiveness of vaccine alone compared with vaccine plus HBIG for the immunization of babies of HBsAg+/HBeAg- mothers.
  
  
  METHODS
  We searched PubMed, Scopus and Cochrane Central Register of Controlled Trials databases to identify studies comparing the effectiveness of combined immunization (vaccine plus HBIG) with vaccine alone in neonates of HBsAg+/HBeAg- mothers. A systematic review and meta-analysis of eligible studies was performed.
  
  
  RESULTS
  A total of nine eligible studies were identified (four randomized controlled trials). No difference was found regarding the primary outcome of our meta-analysis, namely occurrence of hepatitis B infection, between neonates who received vaccine only, compared with those who received both vaccine and HBIG (four studies, 3426 patients, OR=0.82, 95% CI=0.41-1.64). This finding was consistent with regards to seroprotection rate (four studies, 1323 patients, OR=1.24, 95% CI=0.97-1.58). Safety data were not reported in the included studies.
  
  
  CONCLUSIONS
  The available limited published evidence suggests that vaccine alone seems to be equally effective to the combination of HBIG and hepatitis B vaccine for neonates of HBsAg+/HBeAg- mothers in preventing infection. Further studies are needed in order to clarify the potential benefit of combined immunization to this specific subgroup of patients.
authors.affiliation: 2nd Department of Pediatrics, National Kapodistrian University of Athens, School of Medicine, and P. & A. Kyriakou Children's Hospital, Athens, Greece.
authors.forename: Maria
authors.initials: M
authors.lastname: Machaira
authors.affiliation: 3rd Department of Pediatrics, 'Attikon' General University Hospital, Athens, Greece.
authors.forename: Vassiliki
authors.initials: V
authors.lastname: Papaevangelou
authors.affiliation: Alfa Institute of Biomedical Sciences, Athens, Greece.
authors.forename: Evridiki K
authors.initials: EK
authors.lastname: Vouloumanou
authors.affiliation: Alfa Institute of Biomedical Sciences, Athens, Greece.
authors.forename: Giannoula S
authors.initials: GS
authors.lastname: Tansarli
authors.affiliation: Alfa Institute of Biomedical Sciences, Athens, Greece Department of Medicine, Tufts University School of Medicine, Boston, MA, USA m.falagas@aibs.gr.
authors.forename: Matthew E
authors.initials: ME
authors.lastname: Falagas
mesh_terms: D006509:Hepatitis B / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D007136:Immunoglobulins / Q000097:blood*; D007223:Infant; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control* / Q000706:statistics & numerical data; D016017:Odds Ratio; D063868:Patient Outcome Assessment
chemical_list: D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins; C045213:hepatitis B hyperimmune globulin
keywords: HBV; hepatitis B virus; immunization