• Vaccine · Mar 2012

    Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial

    Comparison of safety and immunogenicity of two doses of investigational hepatitis B virus surface antigen co-administered with an immunostimulatory phosphorothioate oligodeoxyribonucleotide and three doses of a licensed hepatitis B vaccine in healthy adults 18-55 years of age.

    • Scott A Halperin, Brian Ward, Curtis Cooper, Gerald Predy, Francisco Diaz-Mitoma, Marc Dionne, Joanne Embree, Allison McGeer, Paul Zickler, Karl-Heinz Moltz, René Martz, Ingo Meyer, Shelly McNeil, Joanne M Langley, Eduardo Martins, William L Heyward, and J Tyler Martin.
    • Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, and Capital Health, Halifax, Canada. scott.halperin@dal.ca
    • Vaccine. 2012 Mar 28; 30 (15): 2556-63.

    BackgroundThe currently licensed aluminum-hydroxide-adjuvanted hepatitis B vaccines require three doses over a 6-month period to achieve high rates of protection in adults. We compared tolerability and immunogenicity of two doses of an investigational hepatitis B vaccine using hepatitis B surface antigen adjuvanted with an immunostimulatory phosphorothioate oligodeoxyribonucleotide (HBV-ISS) to three doses of a licensed alum-adjuvanted vaccine (HBV-Eng).MethodsIn this randomized, observer-blind study, healthy adults received two doses of HBV-ISS at 0 and 4 weeks or three doses of HBV-Eng at 0, 4, and 24 weeks. The primary immunogenicity endpoint was the seroprotection rate (antibody ≥ 10 mIU/mL) 8 weeks after the second dose of HBV-ISS compared to 4 weeks after the third dose of HBV-Eng.ResultsA total of 2415 participants were randomized in a ratio of 3:1 to HBV-ISS (n=1809) and HBV-Eng (n=606). The percentage of subjects exhibiting a seroprotective immune response at the primary time point was significantly higher (95.1%) for HBV-ISS than for HBV-Eng (81.1%). Superiority of the seroprotective rates for HBV-ISS was demonstrated at all time points measured. Geometric mean concentrations were also significantly higher in the HBV-ISS group at all time points measured except at week 28 (24 weeks post-second dose of HBV-ISS and 4 weeks post-third dose HBV-ISS) at which time the antibody concentrations were similar. Both vaccines were welltolerated although injection-site reactions were reported at a higher rate in HBV-ISS recipients.ConclusionsA short, two-dose regimen of HBV-ISS induced a superior antibody response than a three-dose regimen of a licensed hepatitis B vaccine and was well tolerated.Copyright © 2012 Elsevier Ltd. All rights reserved.

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