Randomized Dose Range Study of a Recombinant Hepatitis B Vaccine Produced in Mammalian Cells and Containing the S and PreS2 Sequences

Abstract

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.

Hepatitis B Vaccination in Diabetic Patients: Randomized trial comparing recombinant vaccines containing and not containing pre-S2 antigen

“…No difference in the anti-HBs production has been shown between the two hepatitis B recombinant vaccines containing and not containing the pre-S2 antigen, confirming previous data (10). However, after the GenHevac B vaccine, anti-pre-S2 antibodies appeared earlier than anti-HBs antibodies.…”

“…The addition of the pre-S2 antigen in vaccines has been shown to induce pre-S2 antibodies and could also enhance the response of the antibody to hepatitis B surface antigen (anti-HBs) in mice (8). Whether the addition of the pre-S2 component in vaccines reduce the number of low responders in humans remains controversial (9,10). The aim of this randomized trial was to compare the immunogenicity of hepatitis B recombinant vaccines containing and not containing pre-S2 antigen in diabetic patients and to study the genetic and clinical factors influencing the response.…”

Non-conventional expression systems for the production of vaccine proteins and immunotherapeutic molecules

“…6 Indeed, the GenHevac Ò B vaccine, which contains these viral proteins, is immunogenic in humans. 7,8 The cytomegalovirus (CMV) gB antigen has also been stably expressed in the CHO cell line, leading to the development of a recombinant vaccine that is immunogenic in humans in presence of MF59 as an adjuvant. 9,10 Recently, the CHO cell line was used by GSK (Glaxo Smith Kline, formerly Novartis Vaccines) to produce a pentameric molecule consisting of the human CMV surface proteins gH/gL/UL128/UL130/ UL131A, the pentamer being the main target of neutralizing antibodies in human CMV-seropositive individuals.…”

Replication of Hepatitis B Virus

“…The pgRNA contains critical stem loop structures (ε) at both the 5′ and 3′ ends. 50 The L protein, which has yet another N-terminal extension of 108 to 119 amino acids, has two intracellular topologies. Although nucleocapsids contain host cell proteins, their precise role in replication has yet to be defined.…”