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Drug Evaluation

Heplisav™: A New Hepatitis B Vaccine

Pages 109-117 | Published online: 29 Feb 2008
 

Abstract

Heplisav™ is a vaccine comprising recombinant hepatitis B surface antigen mixed with a synthetic oligonucleotide containing CpG motifs, which stimulates innate immunity. A clinical study demonstrated that Heplisav was significantly more immunogenic compared with Engerix-B in terms of an earlier seroprotection (78.9 vs 11.8%) 4 weeks after the first dose, and 100 versus only 64% seroprotection 4 weeks after the second dose. Geometric mean concentrations also peaked earlier in the Heplisav group. A similar finding was confirmed in a Phase III study in an older (aged >40 years) vaccine-naive population, with 100 versus 73.1% seroprotection in Heplisav versus Engerix-B recipients, respectively, 4 weeks after the third injection. The main adverse events were injection-site reactions, but these were usually mild and self-limiting. In conclusion, Heplisav, a vaccine containing a CpG adjuvant mixed with hepatitis B surface antigen, was more immunogenic and produced earlier seroprotection compared with an existing vaccine, Engerix-B.

Financial & competing interests disclosure

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.

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