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- Title
A Randomized Controlled Phase IIb Trial of Antigen- Antibody Immunogenic Complex Therapeutic Vaccine in Chronic Hepatitis B Patients.
- Authors
Dao-Zhen Xu; Kai Zhao; Li-Min Guo; Xin-Yue Chen; Hui-Fen Wang; Ji-Ming Zhang; Qin Xie; Hong Ren; Wen-Xiang Wang; Lan-Juan Li; Min Xu; Pei Liu; Jun-Qi Niu; Xue-Fan Bai; Xin-Liang Shen; Zheng-Hong Yuan; Xuan-Yi Wang; Yu-Mei Wen
- Abstract
Background: The safety of the immune complexes composed of yeast-derived hepatitis B surface antigen (HBsAg) and antibodies (abbreviated as YIC) among healthy adults and chronic hepatitis B patients has been proved in phase I and phase IIa trial. A larger number of patients for study of dosage and efficacy are therefore needed. Methods and Principal Findings: Two hundred forty two HBeAg-positive chronic hepatitis B patients were immunized withng immunization and 24 weeks after the completion of immunization. The primary endpoint was defined as loss of HBeAg, or presence of anti-HBe antibody or suppression of HBV DNA, while the secondary endpoint was both HBeAg seroconversion and suppression of HBV DNA. Statistical significance was not reached in primary endpoints four weeks after the end of treatment among three groups, however, at the end of follow-up, HBeAg seroconversion rate was 21.8%(17/78) and 9% (7/78 six injections of either 30 μg YIC, 60 μg of YIC or alum adjuvant as placebo at four-week intervals under code. HBV markers and HBV DNA were monitored duri) in the 60 μg YIC and placebo groups respectively (p = 0.03), with 95% confidence intervals at 1.5% to 24.1%. Using generalized estimating equations (GEEs) model, a significant difference of group effects was found between 60 μg YIC and the placebo groups in terms of the primary endpoint. Eleven serious adverse events occurred, which were 5.1%, 3.6%, and 5.0% in the placebo, 30 μg YIC and 60 mg YIC groups respectively (p.0.05). Conclusions: Though statistical differences in the preset primary and secondary endpoints among the three groups were not reached, a late and promising HBeAg seroconversion effect was shown in the 60 mg YIC immunized regimen. By increasing the number of patients and injections, the therapeutic efficacy of YIC in chronic hepatitis B patients will be further evaluated.
- Publication
PLoS ONE, 2008, Vol 3, Issue 7, p1
- ISSN
1932-6203
- Publication type
Academic Journal
- DOI
10.1371/journal.pone.0002565