Results of a phase III clinical trial with an HBsAg-HBIG immunogenic complex therapeutic vaccine for chronic hepatitis B patients: experiences and findings.

TitleResults of a phase III clinical trial with an HBsAg-HBIG immunogenic complex therapeutic vaccine for chronic hepatitis B patients: experiences and findings.
Publication TypeJournal Article
Year of Publication2013
AuthorsXu D-Z, Wang X-Y, Shen X-L, Gong G-Z, Ren H, Guo L-M, Sun A-M, Xu M, Li L-J, Guo X-H, Zhen Z, Wang H-F, Gong H-Y, Xu C, Jiang N, Pan C, Gong Z-J, Zhang J-M, Shang J, Xu J, Xie Q, Wu T-F, Huang W-X, Li Y-G, Xu J, Yuan Z-H, Wang B, Zhao K, Wen Y-M
Corporate AuthorsYIC Efficacy Trial Study Team
JournalJournal of hepatology
Volume59
Issue3
Pagination450-6
Date Published2013 Sep
Abstract

Even though various experimental therapeutic approaches for chronic hepatitis B infection have been reported, few of them have been verified by clinical trials. We have developed an antigen-antibody (HBsAg-HBIG) immunogenic complex therapeutic vaccine candidate with alum as adjuvant (YIC), aimed at breaking immune tolerance to HBV by modulating viral antigen processing and presentation. A double-blind, placebo-controlled, phase II B clinical trial of YIC has been reported previously, and herein we present the results of the phase III clinical trial of 450 patients.

DOI10.1364/OE.21.010772
Alternate JournalJ. Hepatol.