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Safety and immunogenicity of an investigational adjuvanted hepatitis B vaccine (HB-AS02 V) in healthy adults

par Beran, Jirí;Hobzova, Lenka;Wertzova, Veronika;Kuriyakose, Sherine S.O.;Leyssen, Maarten;Surquin, Murielle ;Houard, Sophie
Référence Human vaccines, 6, 7, page (578-584)
Publication Publié, 2010-07

Article révisé par les pairs

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Résumé :

HB-AS02 is an investigational adjuvanted hepatitis B virus (HBV) vaccine for potential use in patients with renal insufficiency and other immunocompromised individuals. In this phase III lot-to-lot consistency study, 450 healthy adult volunteers who had not previously been vaccinated against HBV were randomized to one of three production lots of HB-AS02 at 0 and 1 month and followed until one month after the last vaccine dose. Lot-to-lot consistency was established. High seroprotection rates were already achieved after the first vaccine dose (75.9%). All subjects were seroprotected (anti-HBs antibody concentrations ≥10 mIU/ml) after two doses, with all but one subject achieving anti-HBs antibody concentrations ≥100 mIU/ml (99.7%). Geometric mean anti-HBs antibody concentration was 4594.5 mIU/ml. Local and general symptoms were reported after 80.7% and 45.5% of doses, respectively. However, these were mainly of mild or moderate severity and no subject withdrew from the study due to adverse events. © 2010 Landes Bioscience.