부산대학교 도서관

Abstract: Background: Previous studies have shown that two doses of an investigational hepatitis B vaccine consisting of hepatitis B surface antigen combined with an immunostimulatory phosphorothioate oligodeoxyribonucleotide adjuvant (HBV-ISS) given 8 weeks apart provides seroprotection sooner than 3 doses of a licensed hepatitis B vaccine over 24 weeks. A more rapid schedule with a 4-week interval could provide earlier protection and potentially greater compliance. Methods: In this randomized, double-blind study, healthy adults received two doses of HBV-ISS at 0 and 4 or 0 and 8 weeks; saline placebo was given at week 8 for the 0–4 schedule and at week 4 for the 0–8 schedule). Adverse events were collected after each dose. Antibodies were measured at 0, 4, 8, 12, and 32 weeks. Results: Participants were randomized to the 0–4 (n =18) or 0–8 (n =23) weeks schedule. Rates of adverse events were similar in the two groups after the HBV-ISS injections regardless of the schedule, but more frequent than after the placebo injections. By 4 weeks post-dose-2, 94.1% of 0–4 and 100% of 0–8 recipients had protective antibody levels; geometric mean concentrations were 244mIU/mL and 3217mIU/mL respectively. By 32 weeks, the difference in antibody concentration had decreased (GMC 439mIU/mL vs. 863mIU/mL, respectively; p =0.04). Conclusions: A 0–4 weeks, two-dose regimen of HBV-ISS was well-tolerated and induced an antibody response that was similar to a 0–8 weeks schedule. [Copyright &y& Elsevier]