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Randomized Dose Range Study of a Recombinant Hepatitis B Vaccine Produced in Mammalian Cells and Containing the S and PreS2 Sequences
François Tron, Françoise Degos, Christian Bréchot, Anne-Marie Couroucé, Alain Goudeau, Francois-Noël Marie, Phillippe Adamowicz, Pierre Saliou, Agnès Laplanche, Jean-Pierre Benhamou and Marc Girard
The Journal of Infectious Diseases
Vol. 160, No. 2 (Aug., 1989), pp. 199-204
Published by: Oxford University Press
Stable URL: http://www.jstor.org/stable/30122881
Page Count: 6
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The safety and immunogenicity of different doses (2, 5,10, and 20 µg) 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 gt;90% of the participants. Geometric mean titers of antibodies to HBsAg induced by the 10- and 20-µg 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-µg 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.
The Journal of Infectious Diseases © 1989 Oxford University Press