[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100288750":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":64,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":43,"enrollmentInfo":79,"targetDuration":43,"studyType":82,"phases":83,"briefSummary":86,"conditions":87,"keywords":43,"overallStatus":89,"whyStopped":43,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Vaxine Pty Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard vaccine","ACTIVE_COMPARATOR","Subjects will receive regular intramuscular injections of a commercial hepatitis B vaccine (HBsAg containing aluminium hydroxide adjuvant) according to the same study schedule as the subjects in the experimental arm",[13],"Biological: Commercial Hepatitis B vaccine",{"label":15,"type":16,"description":17,"interventionNames":18},"Experimental therapeutic vaccine","EXPERIMENTAL","Subjects will receive regular intramuscular injections of the experimental therapeutic hepatitis B vaccine (preS HBsAg containing Advax-2 adjuvant) in two cycles with the first cycle of four immunisations administered on days 0, 14, 28, 42. and the second cycle of four immunisations on days 70, 84, 98, and 112.",[19],"Biological: Therapeutic hepatitis B vaccine",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Therapeutic hepatitis B vaccine","HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant",[15],[27],"Hepadvax(TM)",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Commercial Hepatitis B vaccine","Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant",[9],[33],"Engerix B",[35],{"name":36,"affiliation":5,"role":37},"Nikolai Petrovsky, MBBS\u002FPhD","STUDY_DIRECTOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Sharen Pringle, RN","CONTACT","0437033400",null,"admin@arasmi.org",[46],{"facility":47,"status":43,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"ARASMI","Adelaide","South Australia","5046","Australia","AU",{"type":54,"coordinates":55},"Point",[56,57],138.59863,-34.92866,{"lat":57,"lon":56},[60,62],{"name":61,"role":41,"phone":43,"phoneExt":43,"email":43},"Dimitar Sajkov, MBBS, PhD",{"name":61,"role":63,"phone":43,"phoneExt":43,"email":43},"PRINCIPAL_INVESTIGATOR",{"type":65,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[67],{"name":68,"class":69},"Australian Respiratory and Sleep Medicine Institute","OTHER","100288750","phase-1-a-randomised-controlled-phase-1-study-of-vaccine-therapy-for-control-or-cure-of-chronic-hepatitis-b-virus-infection-100288750",false,"NCT03038802","A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection","HBV003","Inclusion Criteria:\n\n* Male or female\n* 18 years of age or older\n* Current evidence of HBV chronic infection (with or without cirrhosis) as indicated by detection of HBsAg and\u002For Hepatitis B DNA (Subjects on current nucleoside therapy may have no detectable Hep B DNA)\n* If child bearing age, using contraception (barrier method, IUD or oral contraception)\n* Able to provide written informed consent\n* Willing and able to comply with the protocol for the duration of the study.\n\nExclusion Criteria:\n\n* Positive for antibody to hepatitis B core antigen (anti-HBc) IgM with negative results for the rest of the HBV markers, indicating acute infection,\n* Positive for anti-delta virus, or anti-hepatitis C virus or HIV\n* Childs Pugh Score for Cirrhosis Mortality of Child grade B or greater\n* Liver transaminases greater than 5 times the upper limit of normal\n* History of severe allergic reaction to hepatitis B vaccine.\n* Pregnancy or female of child-bearing age not using effective method of contraception.\n* Presence of any other organ-specific disease that in the opinion of the investigator may result in risk to the subject from involvement in the study\n* Current alcohol or drug abuse that in the opinion of the investigator may result in non-compliance.\n* Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment","ALL","18 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84,85],"PHASE1","PHASE2","This is a pilot study to determine the safety and efficacy of a novel adjuvanted hepatitis B virus (HBV) vaccine formulated as a potential therapeutic vaccine against chronic HBV infection. An ongoing human clinical trial of this HBV vaccine in a prophylactic setting has confirmed this vaccine to be more effective at inducing seroconversion as measured by development of Hepatitis B surface antibody (HBsAb) in poor responder subjects than the standard alum-adjuvanted HBV vaccine, providing promise that this new vaccine may also be able to induce HBV viral control and\u002For seroconversion in chronically infected subjects",[88],"Chronic Hepatitis b","NOT_YET_RECRUITING","2025-09-16",{"date":92,"type":93},"2025-09-22","ACTUAL",{"date":95,"type":81},"2026-03-01",{"date":97,"type":81},"2027-06-30",{"name":5,"class":6},1]