title: Presence of anti-preS1, anti-preS2, and anti-HBs antibodies in newborns immunized with Bio-Hep-B vaccine.
abstract: BACKGROUND
  An advantage of the third-generation HBV vaccines containing preS1 and preS2 antigens was suggested by their excellent immunogenicity in humans and the rapid onset of antibody response to the S-protein of the vaccine. Sequential studies of the antibody responses to the preS1 and preS2 in relation to the anti-HBs response after immunization with preS-containing vaccines have been made in older children only.
  
  
  METHODS
  Twenty-eight randomly selected, healthy newborns received either 2.5 microg or 5 microg of Bio-Hep-B (preS1, 2+S) vaccine. The children received 3 doses of vaccine according to a 0, 1, 6 months scheme. Antibodies were determined at months 6 and 9.
  
  
  RESULTS
  The vaccine was well tolerated and safe in newborns. Seroconversion and seroprotection were achieved in 100% of newborns after the second injection. No dose-related effect on the anti-HBs response could be observed; GMTs of anti-HBs antibodies after the 2.5 microg and 5.0 microg doses were 6703 and 7104 Kg IU/l, respectively. The induction of measurable levels of antibodies towards preS1- and/or preS2-antigens with 2.5 microg and 5 microg doses of the vaccine was noted in 29% and 50% of the newborns, respectively, at 6 and/or 9 months of vaccination. An augmented anti-HBs response was elicited in the newborns who produced anti-preS2 after vaccination with 2.5 microg compared with 5.0 microg of the vaccine.
  
  
  CONCLUSIONS
  The vaccine Bio-Hep-B can elicit high titers of anti-HBs antibodies in newborns after only two injections. The response of newborns was directed against preS1 + preS2, or preS2 alone.
authors.affiliation: Department of Communicable Disease Control and Prevention, Karolinska Hospital and Microbiology and Tumorbiology Center (MTC), Karolinska Institute, Stockholm, Sweden. kmadalinksi@wp.pl
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Madaliński
authors.forename: Staffan P
authors.initials: SP
authors.lastname: Sylvan
authors.forename: Ulla
authors.initials: U
authors.lastname: Hellstrom
authors.forename: Jolanta
authors.initials: J
authors.lastname: Mikołajewicz
authors.forename: Katarzyna
authors.initials: K
authors.lastname: Dzierzanowska-Fangrat
mesh_terms: D006510:Hepatitis B Antibodies / Q000097:blood*; D006514:Hepatitis B Surface Antigens / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D007231:Infant, Newborn; D011498:Protein Precursors / Q000276:immunology
chemical_list: D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; C050806:presurface protein 1, hepatitis B surface antigen; C050807:presurface protein 2, hepatitis B surface antigen