title: Recombinant DNA hepatitis B vaccine containing Pre-S components of the HBV coat protein--a preliminary study on immunogenicity.
abstract: A novel recombinant hepatitis B vaccine, trademarked Sci-B-Vac, was evaluated for safety, tolerability and immunogenicity in an open label trial performed in Singapore. The experimental vaccine, derived from Chinese hamster ovary (CHO) cells, consists of hepatitis B surface antigen (HBsAg) particles harbouring all three viral envelope polypeptides, the major S protein and the minor Pre-S2 and Pre-S1, in their glycosylated and non-glycosylated forms. The vaccine was administered intramuscularly at 0, 1 and 6 months. No unexpected adverse effects were observed. A high level anti-HBs response to Sci-B-Vac was indicative of its immunogenicity. Subsequent to the third injection, 100% and 92% of the 10 micrograms and 5 micrograms dose recipients, respectively, were seroprotected (anti-HBs titres greater than or equal to 10 mIU ml-1). Moreover, the geometric mean titres (GMT) of the anti-HBs response were very high: 2687 and 1473 mIU ml-1, respectively. An immunogenic advantage of Sci-B-Vac was also suggested by the rapid onset of antibody response: 96% of the 10 micrograms dose recipients were seroprotected with a GMT of 159 mIU ml-1, prior to the third injection.
authors.affiliation: Department of Medicine, National University of Singapore.
authors.forename: I
authors.initials: I
authors.lastname: Yap
authors.forename: R
authors.initials: R
authors.lastname: Guan
authors.forename: S H
authors.initials: SH
authors.lastname: Chan
mesh_terms: D000293:Adolescent; D000328:Adult; D002213:Capsid / Q000276:immunology*; D004274:DNA, Recombinant; D005069:Evaluation Studies as Topic; D005260:Female; D006510:Hepatitis B Antibodies / Q000032:analysis; D017325:Hepatitis B Vaccines; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D014614:Vaccines, Synthetic / Q000008:administration & dosage / Q000276:immunology*; D014761:Viral Hepatitis Vaccines / Q000008:administration & dosage / Q000276:immunology*
chemical_list: D004274:DNA, Recombinant; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D014614:Vaccines, Synthetic; D014761:Viral Hepatitis Vaccines