{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T07:30:26Z","timestamp":1792654226265,"version":"4.5.0"},"reference-count":44,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","license":[{"start":{"date-parts":[[2021,12,8]],"date-time":"2021-12-08T00:00:00Z","timestamp":1638921600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2021,12,8]],"date-time":"2021-12-08T00:00:00Z","timestamp":1638921600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":["Hepatology"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background and Aim<\/jats:title>\n                    <jats:p>\n                      HBV DNA can be reduced using antiviral drugs in patients with chronic hepatitis B (CHB); however, the rate of HBeAg seroconversion remains low. A clinical trial was conducted to assess the efficacy and safety of a\n                      <jats:italic toggle=\"yes\">de novo<\/jats:italic>\n                      designed liposome\u2010based nanoparticle lipopeptide vaccine, \u03b5PA\u201044, for CHB.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Approach and Results<\/jats:title>\n                    <jats:p>\n                      A two\u2010stage phase 2 trial, which included a 76\u2010week, randomized, double\u2010blind, placebo\u2010controlled trial (stage 1) and a 68\u2010week open\u2010label extension (stage 2), was conducted in 15 centers across China (Clinicaltrials.gov No. NCT00869778). In stage 1, 360 human leukocyte antigen A2 (HLA\u2010A2)\u2013positive and HBeAg\u2010positive patients were randomly and equally distributed to receive six subcutaneous injections of 600 \u00b5g or 900 \u00b5g \u03b5PA\u201044 or placebo at week 0, 4, 8, 12, 20, and 28. In stage 2, 183 patients received extended 900 \u00b5g \u03b5PA\u201044, and 26 patients were observed for relapse without further treatment. The primary endpoint was the percentage of patients with HBeAg seroconversion at week 76. At week 76, patients receiving 900 \u00b5g \u03b5PA\u201044 achieved significantly higher HBeAg seroconversion rate (38.8%) versus placebo (20.2%) (95% CI, 6.9\u201029.6%;\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.002). With a combined endpoint of HBeAg seroconversion, alanine aminotransferase normalization and HBV DNA &lt; 2,000 IU\/mL, both 900 \u00b5g (18.1%) and 600 \u00b5g (14.3%), resulted in significantly higher rate versus placebo (5.0%) (\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.002 and\n                      <jats:italic toggle=\"yes\">p<\/jats:italic>\n                      = 0.02, respectively) at week 76. In stage 2, none (0 of 20) of 900 \u00b5g \u03b5PA\u201044\u2010treated patients experienced serologic relapse. The safety profile of \u03b5PA\u201044 was comparable to that of placebo.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Among HLA\u2010A2\u2010positive patients with progressive CHB, a finite duration of 900 \u00b5g \u03b5PA\u201044 monotherapy resulted in significantly higher HBeAg seroconversion rate than placebo and sustained off\u2010treatment effect. A phase 3 trial is ongoing (ChiCTR2100043708).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/hep.32109","type":"journal-article","created":{"date-parts":[[2021,8,16]],"date-time":"2021-08-16T01:27:16Z","timestamp":1629077236000},"page":"182-195","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":35,"title":["Efficacy and safety of a nanoparticle therapeutic vaccine in patients with chronic hepatitis B: A randomized clinical trial"],"prefix":"10.1097","volume":"75","author":[{"given":"Lai","family":"Wei","sequence":"first","affiliation":[{"name":"Peking University People\u2019s Hospital, Peking University Hepatology institute,Beijing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tingting","family":"Zhao","sequence":"additional","affiliation":[{"name":"Chongqing International Institute for Immunology,Chongqing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ji","family":"Zhang","sequence":"additional","affiliation":[{"name":"Institute of Immunology,PLA,Army Medical University,Chongqing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qing","family":"Mao","sequence":"additional","affiliation":[{"name":"Infectious Diseases Institute of PLA,Southwest Hospital,Army Medical University,Chongqing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guozhong","family":"Gong","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,The Second Xiangya Hospital of Central South University,Changsha,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongtao","family":"Sun","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,Tangdu Hospital,Fourth Military Medical University,Xi\u2019an,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongping","family":"Chen","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maorong","family":"Wang","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,The 81th Hospital of PLA,Nanjing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deming","family":"Tan","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,Xiangya Hospital of Central South University,Changsha,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zuojiong","family":"Gong","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,Renmin Hospital of Wuhan University,Wuhan,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Baosen","family":"Li","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,302 Military Hospital,Beijing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junqi","family":"Niu","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,The First Hospital of Jilin University,Changchun,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuchen","family":"Li","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,The Second Affiliated Hospital of Harbin Medical University,Harbin,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huanyu","family":"Gong","sequence":"additional","affiliation":[{"name":"Infectious Diseases Department,The Third Xiangya Hospital of Central South University,Changsha,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liyun","family":"Zou","sequence":"additional","affiliation":[{"name":"Institute of Immunology,PLA,Army Medical University,Chongqing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Zhou","sequence":"additional","affiliation":[{"name":"Institute of Immunology,PLA,Army Medical University,Chongqing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8577-5977","authenticated-orcid":false,"given":"Zhengcai","family":"Jia","sequence":"additional","affiliation":[{"name":"Institute of Immunology,PLA,Army Medical University,Chongqing,China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan","family":"Tang","sequence":"additional","affiliation":[{"name":"Institute of Immunology,PLA,Army Medical 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