[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577579":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":26,"responsibleParty":42,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":26,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":26,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"International Vaccine Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Vaccine administered trans-dermally via MAP","EXPERIMENTAL","Manufacturer: QuadMedicine Inc. Form: Microarray needle patch Appearance: Patch Dose: one patch contains 20μg of HbsAg (drug substance manufactured by LG Chemical)\n\nRoute: Intra-dermal (Skin application)Each patch of vaccine contains the following components:\n\n* HBsAg 20μg (drug substance manufactured by LG Chemical)\n* Sodium carboxymethyl cellulose (CMC Na): 20μg\n* Trehalose: 400μg",[13],"Device: Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Active comparator vaccine via intramuscular injection","ACTIVE_COMPARATOR","Euvax B™ (LG Chemical) is a white, slightly opalescent suspension.1 ml of the above vaccine contains:\n\n* Active ingredient: Purified HBsAg 20µg\n* Adjuvant: Aluminum Hydroxide Gel 0.5 mg\n* Excipients: Potassium phosphate, Sodium phosphate, Sodium chloride",[19],"Biological: Active comparator vaccine via intramuscular injection",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Hepatitis B Vaccine administered trans-dermally via Microneedle Array Patch (MAP)","A total of 40 subjects will be enrolled, 30 subjects administered trans-dermally via Microneedle Array Patch (MAP).",[9],null,{"type":28,"name":15,"description":29,"armGroupLabels":30,"otherNames":26},"BIOLOGICAL","10 subjects administered with active comparator vaccine via intramuscular injection.",[15],[32],{"name":33,"affiliation":34,"role":35},"Hee Soo Kim","Non-governmental Organization","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Sun Bean Kim, Project technical lead","CONTACT","02-8811-098","sunbean.kim@ivi.int",{"type":43,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[45],{"name":46,"class":47},"QuadMedicine","INDUSTRY","100577579","phase-1-hepatitis-b-vaccine-delivered-trans-dermally-by-map-100577579",false,"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,"ALL","19 Years","40 Years",{"count":60,"type":61},40,"ESTIMATED","INTERVENTIONAL",[64],"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.",[67],"Hepatitis B Vaccine",[69],"Microneedle array patch","NOT_YET_RECRUITING","2025-01-24",{"date":73,"type":74},"2025-01-29","ACTUAL",{"date":76,"type":61},"2025-02-05",{"date":78,"type":61},"2026-11-05",{"name":5,"class":6}]