{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,24]],"date-time":"2026-07-24T04:56:29Z","timestamp":1784868989124,"version":"3.55.0"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,1,16]],"date-time":"2025-01-16T00:00:00Z","timestamp":1736985600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Viral Hepatitis"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>Dendritic cells are the most potent antigen\u2010presenting cells in immune therapeutic approaches for chronic hepatitis B (CHB) infection. Here, we developed a clinical trial to evaluate the efficacy and safety of autologous HBV vaccine\u2010pulsed DCs and their induced T cells (HPDCT) in CHB patients. This was a randomised, prospective, open\u2010label, multicentre, superiority study and 309 treatment\u2010naive CHB patients were divided into HPDCT plus nucleos(t)ide analogues (NAs) group (<jats:italic>n<\/jats:italic>\u2009=\u200984), NAs mono\u2010therapy group (<jats:italic>n<\/jats:italic>\u2009=\u200982), HPDCT plus Peg\u2010interferon (Peg\u2010IFN) group (<jats:italic>n<\/jats:italic>\u2009=\u200969), Peg\u2010IFN mono\u2010therapy group (<jats:italic>n<\/jats:italic>\u2009=\u200974). Twelve times of HPDCT vaccinations were given intravenously, and all the patients were followed up for 72\u2009weeks. In total, 1836 HPDCT infusions were administered with no obvious toxicity and side effect although few patients had self\u2010limited low fever. More patients got HBsAg loss in those receiving HPDCT therapy. Patients of HPDCT plus Peg\u2010IFN group with HBV DNA &lt;\u20091\u2009\u00d7\u200910<jats:sup>7<\/jats:sup>\u2009IU\/mL at baseline exhibited earlier, stronger and longer lasting of viral response, especially HBV DNA &lt;\u200920\u2009IU\/mL, than those patients of Peg\u2010IFN mono\u2010therapy group, from week 24 till week 72 (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.05). Comparable efficacy was observed between the patients of HPDCT plus NAs group and NAs mono\u2010therapy groups. In addition, CD25 on CD8<jats:sup>+<\/jats:sup> T cells and HBV\u2010specific CD8<jats:sup>+<\/jats:sup> T cell increased significantly in patients of HPDCT combined antiviral drugs therapy. HPDCT combined with antiviral drugs was safe and able to enhance T cell immunity. Furthermore, HPDCT combined with Peg\u2010IFN could provide an incremental benefit to patients with baseline levels of lower HBV DNA.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/\">ClinicalTrials.gov<\/jats:ext-link> identifier: NCT01935635<\/jats:p>","DOI":"10.1111\/jvh.14045","type":"journal-article","created":{"date-parts":[[2025,1,16]],"date-time":"2025-01-16T09:20:17Z","timestamp":1737019217000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Immunotherapy Using <scp>HBV<\/scp> Vaccine Pulsed <scp>DCs<\/scp> and Induced T\u2010Cells Combined Antiviral Drugs in Treatment Naive <scp>CHB<\/scp> Patients\u2010A Multi\u2010Centre Phase <scp>II<\/scp> Study"],"prefix":"10.1111","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9178-8205","authenticated-orcid":false,"given":"Yurong","family":"Gu","sequence":"first","affiliation":[{"name":"Department of Infectious Diseases The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Gu","sequence":"additional","affiliation":[{"name":"Guangdong Provincial Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lubiao","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jing","family":"Li","sequence":"additional","affiliation":[{"name":"Guangdong Provincial Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chunhong","family":"Liao","sequence":"additional","affiliation":[{"name":"Guangdong Provincial Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanhua","family":"Bi","sequence":"additional","affiliation":[{"name":"Guangdong Provincial Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zexuan","family":"Huang","sequence":"additional","affiliation":[{"name":"Guangdong Provincial Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Cai","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases, Ruijin Hospital Shanghai Jiaotong University School of Medicine  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jia","family":"Wei","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Hepatology The Second People's Hospital of Yunnan Province  Kunming China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuehua","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"},{"name":"Guangdong Provincial Key Laboratory of Liver Disease Research The Third Affiliated Hospital of Sun Yat\u2010Sen University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,1,16]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2012.09.029"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.m2200"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.29800"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.coi.2015.06.016"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.30637"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2008.05.017"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.18632\/aging.202274"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2012.06.009"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2020.04.019"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1128\/JVI.01124\u201008"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2468\u20101253(19)30119\u20100"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365\u20102893.2010.01320.x"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.3748\/wjg.v11.i12.1806"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.vaccine.2010.01.038"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2015.06.019"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2019.06.028"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41571\u2010022\u201000600\u2010w"},{"key":"e_1_2_11_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470\u20102045(22)00326\u20106"},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140\u20106736(23)00961\u20103"},{"key":"e_1_2_11_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/sji.12097"},{"key":"e_1_2_11_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep.21187"},{"key":"e_1_2_11_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2020.11.025"},{"key":"e_1_2_11_24_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41590\u2010020\u20100731\u20104"},{"key":"e_1_2_11_25_1","doi-asserted-by":"publisher","DOI":"10.1126\/scitranslmed.aaf9194"},{"key":"e_1_2_11_26_1","doi-asserted-by":"publisher","DOI":"10.1159\/000491972"},{"key":"e_1_2_11_27_1","doi-asserted-by":"publisher","DOI":"10.1111\/imr.12686"},{"key":"e_1_2_11_28_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.immuni.2016.04.008"},{"key":"e_1_2_11_29_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2015.11.050"},{"key":"e_1_2_11_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jhep.2019.08.024"},{"key":"e_1_2_11_31_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.ppat.1007690"}],"container-title":["Journal of Viral Hepatitis"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/jvh.14045","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,9]],"date-time":"2025-02-09T20:59:03Z","timestamp":1739134743000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/jvh.14045"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,1,16]]},"references-count":30,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1111\/jvh.14045"],"URL":"https:\/\/doi.org\/10.1111\/jvh.14045","archive":["Portico"],"relation":{},"ISSN":["1352-0504","1365-2893"],"issn-type":[{"value":"1352-0504","type":"print"},{"value":"1365-2893","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,1,16]]},"assertion":[{"value":"2024-08-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-11-30","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-01-16","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e14045"}}