[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatitis-b-vaccine\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatitis-b-vaccine":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100577828","research-on-clinical-recovery-and-maintenance-strategies-for-chb-100577828",false,"NCT06803368","Research on Clinical Recovery and Maintenance Strategies for CHB","Research on Clinical Recovery and Maintenance Strategies for Chronic Hepatitis B","Inclusion Criteria:\n\n* Age between 18 and 65 years old;\n* Gender is not limited;\n* CHB patients who meet the diagnostic criteria of the 2019 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B \\[5\\];\n* Confirmed interferon treatment resulted in HBsAg disappearance, HBeAg negativity, and HBV DNA below the lower detection limit and cessation Patients treated with interferon;\n* Sign a written informed consent form.\n\nExclusion Criteria:\n\n* Merge with other hepatitis virus (HCV, HDV) infections;\n* Autoimmune liver disease;\n* HIV infection;\n* Long term alcohol abuse and\u002For other liver damaging drugs;\n* Mental illness;\n* Evidence of liver tumors (liver cancer or AFP\\>100ng\u002Fml);\n* Decompensated cirrhosis;\n* Individuals with serious diseases of the heart, brain, lungs, kidneys, and other systems who cannot participate in long-term follow-up.","ALL","18 Years","65 Years",{"count":20,"type":21},285,"ESTIMATED","INTERVENTIONAL",[24],"NA","Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations will be conducted every 3-6 months, and blood samples will be retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.",[27,28],"Chronic Hepatitis b","Hepatitis B Vaccine","RECRUITING","2025-01-26",{"date":32,"type":33},"2025-01-31","ACTUAL",{"date":35,"type":33},"2024-11-01",{"date":37,"type":21},"2027-10-30",{"name":39,"class":40},"Beijing Municipal Administration of Hospitals","OTHER_GOV",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":16,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100577579","phase-1-hepatitis-b-vaccine-delivered-trans-dermally-by-map-100577579","NCT06800131","Hepatitis B Vaccine Delivered Trans-dermally by MAP","A Phase I, Randomized, Open-Label, Active-Control Study to Evaluate Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Delivered Trans-dermally by Microneedle Array Patch (MAP) in Healthy Adults","Inclusion Criteria:\n\n1. Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures\n2. Adults aged 19 to 40 years\n3. Judged to be healthy by the Investigator on the basis of medical history, physical examination, screening laboratory results and vital signs performed at screening visit\n4. Able and willing to comply with all study procedures during the study period\n5. Negative serological tests for Hepatitis B surface antigen (HBsAg), Hepatitis B surface antibody (Anti-HBs), antibody to Hepatitis B core antibody (anti-HBc), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody at screening\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 3 months following last dose\n2. Positive serum pregnancy test at screening or positive urine pregnancy test prior at dosing visit\n3. Self-reported history of Hepatitis B vaccination beyond childhood Hepatitis B immunization series\n4. Currently participating in or has participated in a study with an investigational product administered within 6 months preceding Day 0\n5. Body mass index (BMI) \\\u003C18 or \\>30 kg\u002Fm²\n6. Current or history of the following medical conditions:\n\n   * Diagnosis of malignancy within 5 years of screening\n   * Diagnosis of diabetes mellitus or HbA1c ≥7%\n   * Liver transaminases \\> 2 times the upper limit of the normal range\n   * Impaired renal function as creatinine \\>120 mmol\u002FL or calculated glomerular filtration rate \\\u003C60mls\u002Fmin\n   * Use of immunoglobulin or blood products in last 3 months\n   * History of severe allergic reaction or anaphylaxis after immunization or administration of any medical products that contain drug substances of investigational product",true,"19 Years","40 Years",{"count":53,"type":21},40,[55],"PHASE1","This is Phase I, randomized, open-label, active-controlled study to evaluate the safety, tolerability, and immunogenicity of a hepatitis B vaccine administered trans-dermally via microneedle array patch (MAP) compared to the intra-muscular (IM) hepatitis B vaccine (Euvax B™), administered at Day (D) 0, Week (W) 4, W26 among healthy adults aged 19 to 40 years in the Republic of Korea.",[28],[59],"Microneedle array patch","NOT_YET_RECRUITING","2025-01-24",{"date":63,"type":33},"2025-01-29",{"date":65,"type":21},"2025-02-05",{"date":67,"type":21},"2026-11-05",{"name":69,"class":70},"International Vaccine Institute","OTHER"]