Safety and immunogenicity of a new mammalian cell-derived recombinant hepatitis B vaccine containing Pre-S1 and Pre-S2 antigens in adults.
BACKGROUND
Previous data showed that new recombinant hepatitis B virus vaccine, which contains the S-protein component of the HBV surface together with the Pre-S1 and Pre-S2, is considerably more immunogenic than a second-generation recombinant HBV vaccine.


OBJECTIVE
To compare the immunogenicity and safety of a novel recombinant HBV vaccine S1, Pre-S1 and Pre-S2 protein components of the hepatitis B surface antigen--BioHep, 10 micrograms dose, to a licensed vaccine containing only the S-protein component--Engerix-B, 20 micrograms dose.


METHODS
A prospective randomized study included 524 adults--260 in the Bio-Hep group and 264 in the Engerix-B group. Both vaccines were administered in a three-dose regimen given at 0, 1 and 6 months, and adverse events were recorded on a diary card 5 days after each vaccination. Immunogenicity was tested by measuring anti-hepatitis B surface antibody.


RESULTS
One month after the third injection, 98% of the BioHep subjects were found to be seroprotected vs. 85.1% of the Engerix-B group. In addition, the geometric mean titers were 2,203 mIU/ml and 326 mIU/ml in the Bio-Hep-B and Engerix-B groups respectively. An immunogenic advantage of Bio-Hep-B was suggested by the rapid onset of antibody response--66.5% were seroconverted one month after the first injection as compared to 19.3% in the Engerix-B group. No unexpected adverse events were observed, and the recorded events were mild in both groups.


CONCLUSIONS
BioHep, a novel recombinant HBV vaccine containing S, Pre-S1 and Pre-S2 protein components, at a lower dose, is safe and more immunogenic than the conventional HBV vaccine that contains only S protein.
Raz
R
R
Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel. raz_r@clalit.org.il
Koren
R
R
Bass
D
D
D000293:Adolescent; D000328:Adult; D000818:Animals; D005260:Female; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011498:Protein Precursors / Q000276:immunology*; D013997:Time Factors; D014614:Vaccines, Synthetic / Q000276:immunology*; D014759:Viral Envelope Proteins / Q000276:immunology*
C075654:Engerix-B; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; D014614:Vaccines, Synthetic; D014759:Viral Envelope Proteins; C050806:presurface protein 1, hepatitis B surface antigen; C050807:presurface protein 2, hepatitis B surface antigen