Abstract
BackgroundSci-B-Vac™ is a recombinant, hepatitis B vaccine derived from a mammalian cell line and containing hepatitis B surface antigen (HBsAg) as well as preS1 and preS2 antigens. Few studies have been performed on the antibody responses to preS1 in relation to the antibody to hepatitis B surface antigen (anti-HBs) response during immunisation of healthy children with preS-containing vaccines.ResultsIn this study 28 healthy newborns were randomly selected to receive either 2.5 ug or 5.0 ug of the Sci-B-Vac vaccine. Children received three doses of vaccine according to a 0-, 1-, 6-month scheme. Antibodies against the S-protein and three synthetic peptides mimicking three B-cell preS1 epitopes, (21–32 amino acid epitope), (32–47 amino acid epitope) and the C-terminal (amino acid epitope 94–117) were determined at 6 and 9 months. Fourteen (50%) of the 28 newborns had detectable levels of anti-preS1 (21–32) antibodies; 15 (54%) were anti-preS1 (32–47) reactive and 12 (43%) were anti-preS1 (94–117) reactive at 6 or 9 months after initiation of the vaccination. Significantly higher levels of anti-HBs were observed in the sera of patients with detectable anti-preS1 (32–47) reactivity (24 550 ± 7375 IU/L, mean ± SEM) as compared with the non-reactive sera (5991 ± 1530 IU/L, p < 0.05). The anti-HBs levels were significantly lower if none (p < 0.05) or one (p < 0.025) of the preS1 (21–32, 32–47, 94–117) peptides were recognised compared with the anti-HBs levels if two or three peptides were recognised.ConclusionRecognition of several preS1 epitopes, and in particular, the epitope contained within the second half of the hepatocyte binding site localised in the hepatitis B surface protein of the third-generation hepatitis B vaccine is accompanied by a more pronounced antibody response to the S-gene-derived protein in healthy newborns.
Highlights
Sci-B-VacTM is a recombinant, hepatitis B vaccine derived from a mammalian cell line and containing hepatitis B surface antigen (HBsAg) as well as preS1 and preS2 antigens
We found that recognition of several preS1 epitopes, and in particular, the epitope contained within the second half of the hepatocyte binding site localised in the hepatitis B surface protein of the third-generation hepatitis B vaccine is accompanied by a more pronounced antibody response to the S-gene-derived protein in healthy newborns
The presence of IgG antibodies with specificity for the synthetic peptide analogues corresponding to the preS1 (21– 32), (32–47) and (94–117) regions of the hepatitis B virus (HBV) was studied using peptide-based enzyme-linked immunosorbent assay (ELISA) at a 1/125 dilution of sera
Summary
Sci-B-VacTM is a recombinant, hepatitis B vaccine derived from a mammalian cell line and containing hepatitis B surface antigen (HBsAg) as well as preS1 and preS2 antigens. Infectious particles of hepatitis B virus (HBV), called Dane particles, consist of viral nucleic acid encapsulated within a core particle enveloped by three distinct virus-coded surface proteins. These three proteins, termed preS1, preS2 and S, are co-terminal at the C-terminus but are different (page number not for citation purposes). Within the preS1 protein, the 21–47 amino acid epitope was shown to mediate binding to the cell surface of HepG2 cells [4] Antibodies directed against this epitope were shown to have virus-neutralising activity [5]. The hepatitis B surface antigen(HBsAg) preS1 region is highly immunogenic, containing both sequential and conformational epitopes [9] with abundant T- and B-cell epitopes [10,11,12,13,14,15]
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