title: Comparative Efficacy, Safety and Immunogenicity of Hepavax-Gene TF and Engerix-B Recombinant Hepatitis B Vaccines in Neonates in China.
abstract: The aim of the study was to compare efficacy, immunogenicity and safety of Hepavax-Gene TF (thimerosal-free) vaccine with comparator in Chinese neonates.
  
  
  
  A double-blind, randomized, parallel-group, stratified study was conducted at multiple sites in China in healthy neonates, consisting of 3 doses of Hepavax-Gene TF or Engerix-B vaccines administered at birth, 1 and 6 months of age, with a 6-month follow-up after vaccination. On the basis of hepatitis B virus (HBV) infection status of mothers, infants were assigned to one of 2 study strata for mothers positive for HBV infection (stratum 1), with or without active replicating virus (substrata 1a, 1b), and for HBV negative mothers (stratum 2).
  
  
  
  Mother-to-child HBV transmission was prevented in >95% of neonates immunized with Hepavax-Gene TF in stratum 1 at all timepoints and was noninferior to Engerix-B. Seroprotection rates (anti-HBs antibody ≥10 IU/L) at 1 and 6 months postvaccination for Hepavax-Gene TF were over 90% for all exposed neonates. Immunogenicity of Hepavax-Gene was noninferior to Engerix-B except for neonates in substratum 1a at 12 months. Geometric mean concentrations between vaccine groups were not significantly different for neonates at all timepoints except in substratum 1b at 7 months. Both vaccines were well tolerated and had similar local and systemic adverse event profiles.
  
  
  
  Hepavax-Gene TF vaccine was equally effective and noninferior to Engerix-B in terms of prevention of mother-to-child HBV transmission in neonates born to mothers positive for hepatitis B surface antigen. Both vaccines elicited seroprotective levels in >90% of all exposed neonates at 12-month follow-up. Both vaccines were well tolerated with similar adverse event profiles.
authors.affiliation: From the *Center for Disease Control and Prevention Jiangsu Province, Nanjing, People's Republic of China; †Department of Crucell Integration, Janssen Research & Development, Beerse, Belgium; ‡Department of Pharmacovigilance, Janssen Vaccines AG, Berne, Switzerland; §Department of Model Based Drug Development, Janssen Research & Development, Beerse, Belgium; and ¶Department of Clinical Development, Janssen Vaccines AG, Berne, Switzerland.
authors.forename: Fengcai
authors.initials: F
authors.lastname: Zhu
authors.forename: Henri
authors.initials: H
authors.lastname: Deckx
authors.forename: Raphaele
authors.initials: R
authors.lastname: Roten
authors.forename: Bart
authors.initials: B
authors.lastname: Michiels
authors.forename: Michal
authors.initials: M
authors.lastname: Sarnecki
mesh_terms: D002681:China; D005260:Female; D006509:Hepatitis B / Q000453:epidemiology / Q000517:prevention & control* / Q000635:transmission; D006510:Hepatitis B Antibodies / Q000097:blood*; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D007231:Infant, Newborn; D008297:Male
chemical_list: C075654:Engerix-B; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines