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

BACKGROUND & AIMS: 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. METHODS: Twelve doses of either YIC or alum alone as placebo were administered randomly to 450 CHB patients and they were followed for 24weeks after the completion of immunization. The primary end point was HBeAg seroconversion, and the secondary end points were decrease in viral load, improvement of liver function, and histology. RESULTS: In contrast to the previous phase II B trial using six doses of YIC and alum as placebo, six more injections of YIC or alum resulted in a decrease of the HBeAg seroconversion rate from 21.8% to 14.0% in the YIC group, but an increase from 9% to 21.9% in the alum group. Decrease in serum HBV DNA and normalization of liver function were similar in both groups (p>0.05). CONCLUSIONS: Overstimulation with YIC did not increase but decreased its efficacy due to immune fatigue in hosts. An appropriate immunization protocol should be explored and is crucial for therapeutic vaccination. Multiple injections of alum alone could have stimulated potent inflammatory and innate immune responses contributing to its therapeutic efficacy, and needs further investigation.

Electrospinning preparation and photoluminescence properties of erbium complex doped composite fibers.

In this paper, an Er(III) complex of Er(DBM)3IPD, where DBM=1,3-diphenyl-propane-1,3-dione and IPD=4-(1H-imidazo[4,5-f][1,10]phenanthrolin-2-yl)-N,N-diphenylaniline, is synthesized and doped into poly(vinylpyrrolidone) submicron fibers through electrospinning technique. The crystal structure and morphology are investigated in detail. The composite fibers exhibit smooth and uniform morphology on the substrate, with an average diameter of ∼1.4 µm. Photophysical data suggest that DBM ligand sensitizes Er(III) center efficiently and provides an optimal condition for radiative decay, and low temperature can enhance the emission intensity by suppressing the quenching effect. It is found that the photostability of Er(III) complex doped composite fibers is largely improved compared with that of pure complex.

A promising phosphorescent iridium complex with fluorine substituents: synthesis, crystal structure, photo- and electro-luminescence performance.

In this paper, we report a phosphorescent Ir(III) emitter of Ir(acac-F6)(F-BT)(2), where acac-F6 = 1,1,1,5,5,5-hexafluoropentane-2,4-dione and F-BT = 2-(2-fluorophenyl)benzo[d]thiazole, including its crystal structure, electronic nature, photophysical characteristics, thermal and electrochemical properties. Data suggest that Ir(acac-F6)(F-BT)(2) is a promising emitter with high quantum yield of 0.19 and good thermal stability, along with its proper energy levels for charge carrier transportation. Electroluminescence (EL) devices using Ir(acac-F6)(F-BT)(2) as emitter are also fabricated, and their electroluminescence performances are investigated in detail. The optimal EL device shows a maximum luminance of 27,000 cd/cm(2) and a peak current efficiency of 8.7 cd/A.