Randomized dose range study of a recombinant hepatitis B vaccine produced in mammalian cells and containing the S and PreS2 sequences.
The safety and immunogenicity of different doses (2, 5, 10, and 20 micrograms of a recombinant hepatitis B virus (rHBV) vaccine containing the S and PreS2 sequences and produced in mammalian cells were compared to those of a plasma-derived hepatitis B virus vaccine (Hevac B Pasteur) in 482 volunteers. Local and general side effects were mild and transient. No transaminase level elevation and autoantibody production were observed. The antibody to hepatitis B surface antigen (HBsAg) seroconversion rates did not differ in the groups receiving the rHBV vaccine and the subjects receiving the plasma-derived vaccine. Both vaccines elicited levels of antibodies to HBsAg in greater than 90% of the participants. Geometric mean titers of antibodies to HBsAg induced by the 10- and 20-micrograms doses of the rHBV vaccine did not differ from that induced by the plasma-derived vaccine and were higher than those induced by the 2- and 5-micrograms rHBV vaccine doses. The striking feature of the rHBV vaccine compared to the plasma-derived vaccine was an early and high production of antibodies to PreS2, which may constitute an advantage in prevention of hepatitis B virus infection.
Tron
F
F
Pasteur Vaccins, Marnes-la-Coquette, France.
Degos
F
F
Bréchot
C
C
Couroucé
A M
AM
Goudeau
A
A
Marie
F N
FN
Adamowicz
P
P
Saliou
P
P
Laplanche
A
A
Benhamou
J P
JP
D000293:Adolescent; D000328:Adult; D005260:Female; D006510:Hepatitis B Antibodies / Q000032:analysis; D006514:Hepatitis B Surface Antigens / Q000276:immunology*; D017325:Hepatitis B Vaccines; D006801:Humans; D008297:Male; D011498:Protein Precursors / Q000276:immunology*; D011994:Recombinant Proteins / Q000009:adverse effects / Q000276:immunology; D014761:Viral Hepatitis Vaccines / Q000009:adverse effects / Q000276:immunology*
D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011498:Protein Precursors; D011994:Recombinant Proteins; D014761:Viral Hepatitis Vaccines; C050807:presurface protein 2, hepatitis B surface antigen