title: Safety and immunogenicity of a novel mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in children.
abstract: We tested the safety and immunogenicity of the new recombinant hepatitis B virus (HBV) vaccine produced via expression of the Pre-S1, Pre-S2 and S protein components of the hepatitis B surface antigen (HBsAg). A reduced dose (2.5 micrograms) of the vaccine (Bio-Hep-B) was tested in children aged 4-9 years and was compared to a 10 microgram dose of a licensed vaccine (Engerix-B) in a randomized manner. Both vaccines were administered in 3 doses (0, 1 and 6 month intervals). Adverse events were collected 5 days following each vaccination by a diary card provided to the parents. Immunogenicity was tested by measuring anti-hepatitis B surface antibody (anti-HBs). A total of 217 children were enrolled (162 in the Bio-Hep-B group and 55 in the Engerix-B group). Total adverse events were observed in 35% of the Bio-Hep-B group and 33% of the Engerix-B group, with no differences when each of the potential adverse events was considered. Titers were within the expected range (geometric mean titers post dose 1, 2 and 3 were 45.8, 8360.2 and 1445.7, respectively, for Bio-Hep-B and 36.3, 10316.1 and 1898.7, respectively, for Engerix-B). A trend toward better immunogenicity with Bio-Hep-B was observed at early visits when measured by both seroconversion (anti-HBs > or = 2.1 mIU ml-1) rate and seroprotection (anti-HBs > or = 10 mIU ml-1) rate; however, statistical significance was not reached. We conclude that in children, Bio-Hep-B vaccine at a reduced dose was as safe and as immunogenic as Engerix-B given at the regular pediatric dosage.
authors.affiliation: Infectious Disease Unit, Soroka University Medical Center, Beer-Sheva, Israel.
authors.forename: R
authors.initials: R
authors.lastname: Raz
authors.forename: R
authors.initials: R
authors.lastname: Dagan
authors.forename: A
authors.initials: A
authors.lastname: Gallil
authors.forename: G
authors.initials: G
authors.lastname: Brill
authors.forename: I
authors.initials: I
authors.lastname: Kassis
authors.forename: R
authors.initials: R
authors.lastname: Koren
mesh_terms: D002648:Child; D002675:Child, Preschool; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control*; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000009:adverse effects* / Q000276:immunology; D006515:Hepatitis B virus / Q000276:immunology*; D006801:Humans; D007557:Israel; D008297:Male; D011498:Protein Precursors / Q000276:immunology*; D011994:Recombinant Proteins / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects* / Q000276:immunology; D014759:Viral Envelope Proteins / Q000276:immunology*
chemical_list: C075654:Engerix-B; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; D011994:Recombinant Proteins; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; C050806:presurface protein 1, hepatitis B surface antigen; C050807:presurface protein 2, hepatitis B surface antigen