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Phase Ⅱb trial of in vivo electroporation mediated dualplasmid hepatitis B virus DNA vaccine in chronic hepatitis B patients under lamivudine therapy

引用

World Journal of Gastroenterology 2017年第2期23卷 306-317页

作者： Fu-Qiang Yang Gui-Rong Rao Gui-Qiang Wang Yue-Qi Li Yao Xie Zhan-Qing Zhang Cun-Liang Deng Qing Mao Jun Li Wei Zhao Mao-Rong Wang Tao Han Shi-Jun Chen Chen Pan De-Ming Tan Jia Shang Ming-Xiang Zhang Yue-Xin Zhang Ji-Ming Yang Guang-Ming Chen Liver Disease Research Center 458~(th) Hospital of PLA Department of Infectious Diseases Peking University First Hospital Beijing 302 Hospital Ninth Clinical Department Beijing Ditan Hospital Department of Liver Diseases Public Health Center Fudan University Department of Infectious Diseases Affiliated Hospital of Luzhou Medical College PLA Institute of Infectious Diseases Southwest Hospital Third Military Medical University Jiangsu Province People’s Hospital Nanjing 2~(nd) Hospital Nanjing PLA 81 Hospital Tianjin 3~(rd) Center Hospital Jinan Infectious Disease Hospital Fuzhou Infectious Disease Hospital Xiangya Hospital Central South University Henan Provincial People’s Hospital The Sixth People’s Hospital of Shenyang The First Affiliated Hospital of Xinjiang Medical University Infectious Disease Hospital of Tianjin

AIM To assess the efficacy and safety of in vivo electroporation(EP)-mediated dual-plasmid hepatitis B virus(HBV) DNA vaccine vs placebo for sequential combination therapy with lamivudine(LAM) in patients with chronic hepatitis B. METHODS Two hundred and twenty-five patients were randomized to receive either LAM + vaccine(vaccine group, n = 109) or LAM + placebo(control group, n = 116). LAM treatment lasted 72 wk. Patients received the DNA vaccine or placebo by intramuscular injection mediated by EP at weeks 12(start of treatment with vaccine or placebo, SOT), 16, 24, and 36(end of treatment with vaccine or placebo, EOT). RESULTS In the modified intent-to-treat population, morepatients had a decrease in HBV DNA > 2 log10 IU/m L in the vaccine group at week 12 after EOT compared with the control group. A trend toward a difference in the number of patients with undetectable HBV DNA at week 28 after EOT was obtained. Adverse events were similar. In the dynamic per-protocol set, which excluded adefovir(ADV) add-on cases at each time point instantly after ADV administration due to LAM antiviral failure, more patients had a decrease in HBV DNA > 2 log10 IU/mL in the vaccine group at week 12 and 28 after EOT compared with the control group. More patients with undetectable HBV DNA at week 28 after EOT in the vaccine group were also observed. Among patients with a viral load < 1000 copies/mL at week 12, more patients achieved HBeA g seroconversion in the vaccine group than among controls at week 36 after EOT, as well as less virological breakthrough and YMDD mutations. CONCLUSION The primary endpoint was not achieved using the HBV DNA vaccine. The HBV DNA vaccine could only be beneficial in subjects that have achieved initial virological response under LAM chemotherapy.

关键词： Chronic hepatitis B DNA vaccine In vivo electroporation Lamivudine-resistant mutants randomized placebo-controlled trial

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