[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583324":3},{"organization":4,"armGroups":7,"interventions":41,"overallOfficials":64,"centralContacts":69,"locations":74,"responsibleParty":92,"collaborators":46,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":46,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":46,"enrollmentInfo":104,"targetDuration":46,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":77,"whyStopped":46,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"Guangzhou Patronus Biotech Co., Ltd.","INDUSTRY",[8,14,19,25,31,36],{"label":9,"type":10,"description":11,"interventionNames":12},"Low dose antigen and low dose adjuvant of LYB004","EXPERIMENTAL","Subjects aged 40 years and older will be vaccinated with 2 doses of LYB004 (low dose antigen and low dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM).",[13],"Biological: Low dose antigen and low dose adjuvant of LYB004",{"label":15,"type":10,"description":16,"interventionNames":17},"Low dose antigen and high dose adjuvant of LYB004","Subjects aged 40 years and older will be vaccinated with 2 doses of LYB004 (low dose antigen and high dose adjuvant ) on a 0, 2 month schedule, administered intramuscularly (IM).",[18],"Biological: Low dose antigen and high dose adjuvant of LYB004",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Subjects aged 40 years and older will be vaccinated with 2 doses of placebo on a 0, 2 month schedule, administered intramuscularly (IM).",[24],"Biological: Placebo",{"label":26,"type":27,"description":28,"interventionNames":29},"Positive control","ACTIVE_COMPARATOR","Subjects aged 50 years and older will be vaccinated with 2 doses of Shingrix® on a 0, 2 month schedule, administered intramuscularly (IM).",[30],"Biological: Positive control",{"label":32,"type":10,"description":33,"interventionNames":34},"High dose antigen and low dose adjuvant of LYB004","Subjects aged 40 years and older will be vaccinated with 2 doses of LYB004 (high dose antigen and low dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM).",[35],"Biological: High dose antigen and low dose adjuvant of LYB004",{"label":37,"type":10,"description":38,"interventionNames":39},"High dose antigen and high dose adjuvant of LYB004","Subjects aged 40 years and older will be vaccinated with 2 doses of LYB004 (high dose antigen and high dose adjuvant) on a 0, 2 month schedule, administered intramuscularly (IM).",[40],"Biological: High dose antigen and high dose adjuvant of LYB004",[42,47,50,53,56,59],{"type":43,"name":9,"description":44,"armGroupLabels":45,"otherNames":46},"BIOLOGICAL","0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01C.",[9],null,{"type":43,"name":15,"description":48,"armGroupLabels":49,"otherNames":46},"0.5 mL per dose, containing a total of 25 μg VZV-gEM adjuvanted with A01B.",[15],{"type":43,"name":32,"description":51,"armGroupLabels":52,"otherNames":46},"0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01C.",[32],{"type":43,"name":37,"description":54,"armGroupLabels":55,"otherNames":46},"0.5 mL per dose, containing a total of 50 μg VZV-gEM adjuvanted with A01B.",[37],{"type":43,"name":20,"description":57,"armGroupLabels":58,"otherNames":46},"0.5 mL per dose, without antigen and adjuvant.",[20],{"type":43,"name":26,"description":60,"armGroupLabels":61,"otherNames":62},"0.5 mL per dose, containing a total of 50 µg recombinant varicella zoster virus glycoprotein E, adjuvanted with AS01B.",[26],[63],"Shingrix®",[65],{"name":66,"affiliation":67,"role":68},"Renfeng Fan","Guangdong Center for Disease Prevention and Control","PRINCIPAL_INVESTIGATOR",[70],{"name":66,"role":71,"phone":72,"phoneExt":46,"email":73},"CONTACT","8613560231815","gdsjkzx_sws_sps@gd.gov.cn",[75],{"facility":76,"status":77,"city":78,"state":46,"zip":46,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":86,"contacts":87},"Guangdong Provincial Center for Disease Control and Prevention","RECRUITING","Meizhou","China","CN",{"type":82,"coordinates":83},"Point",[84,85],116.11768,24.28859,{"lat":85,"lon":84},[88],{"name":89,"role":71,"phone":90,"phoneExt":46,"email":91},"Weihua Huang","8613690896555","2051274292@qq.com",{"type":93,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100583324","phase-1-safety-and-immunogenicity-of-the-recombinant-zoster-vaccine-lyb004-in-adults-aged-40-years-and-older-100583324",false,"NCT06874842","Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older","A Phase I, Randomized, Observer-blinded, Parallel-Controlled, Dose Escalation Clinical Trial to Assess the Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older","Inclusion Criteria:\n\n1. Residents aged 40 years and older (at the time of screening), regardless of gender;\n2. Participants can provide valid identification, voluntarily agree to participate in the study, and sign the Informed Consent Form;\n3. Participants are able to attend all planned follow-up visits and comply with the protocol requirements;\n4. Females of childbearing potential should use effective contraceptive measures one month before enrollment; females of childbearing potential (excluding those who have undergone tubal ligation, bilateral oophorectomy, or hysterectomy) and male participants should practice effective contraception and avoid pregnancy plans, as well as sperm or egg donation plans from the time of enrollment until 6 months after the full course of vaccination. Effective contraceptive methods include oral contraceptives (excluding emergency contraceptives), injectable or implantable contraceptives, sustained-release local contraceptives, contraceptive patches, intrauterine devices, sterilization, abstinence, condoms, diaphragms, cervical caps, etc.\n\nExclusion Criteria:\n\n1. Axillary temperature ≥ 37.3°C;\n2. History of herpes zoster before vaccination with the investigational vaccine;\n3. Previous vaccination against HZ or varicella;\n4. Has had close contact with patients with varicella\u002Fherpes zoster within 6 months before vaccination with the investigational vaccine;\n5. Has received any vaccine within 14 days before vaccination, or have received a live vaccine within 28 days;\n6. Have been injected with gamma globulin or intravenous immunoglobulin within 3 months before vaccination;\n7. Individual with the following diseases: ① Have acute diseases or are in the acute exacerbation period of chronic diseases, or take antipyretic, analgesic, and anti-allergic drugs within 3 days before vaccination; ② Allergies to any component of the study vaccine, or have a history of severe allergic reactions to any vaccination; ③ History of convulsions, epilepsy, encephalopathy (such as congenital brain dysplasia, brain trauma, brain tumors, cerebral hemorrhage, cerebral infarction, brain infection, chemical poisoning, etc. causing brain nerve tissue damage, etc.) and mental illness, or a family history of mental illness; ④ Asplenia, or functional asplenia; ⑤Primary or secondary immunodeficiency, or diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune diseases; ⑥ Chronic administration (≥14 consecutive days) of glucocorticoid (reference value for dose: ≥ 2mg\u002Fkg\u002Fday or ≥ 20mg\u002Fday prednisone or equivalent) or other immunosuppressive agents within the past 3 months, with the exception of inhaled or topical steroids, or short-term use (\\\u003C14 consecutive days) of oral corticosteroids; ⑦ Severe cardiovascular diseases (pulmonary heart disease, pulmonary edema, etc.), severe liver and kidney diseases, complicated diabetes; ⑧ History of thrombocytopenia or other coagulation disorders that may contraindicate intramuscular injection;⑨Severe hypertension that cannot be controlled by medication (on-site measurement: systolic blood pressure ≥ 140mmHg and\u002For diastolic blood pressure ≥ 90mmHg);\n8. Abnormal laboratory test indicators specified in the protocol before vaccination and determined by the clinical investigator to be of clinical significance;\n9. History of long-term alcohol abuse and\u002For drug abuse;\n10. Individual who is currently participating in other research or unregistered product (drugs, vaccines, or devices, etc.) clinical studies, or plan to participate in other clinical studies before the end of this clinical study;\n11. Exclusion criteria for specific populations: lactating or pregnant women during the clinical research period, or women of childbearing age with a positive pregnancy test before vaccination;\n12. Other conditions that may impact the subject's safety or influence the assessment of vaccine response, as determined by the investigator.",true,"ALL","40 Years",{"count":105,"type":106},92,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.",[112],"Herpes Zoster (HZ)",[114,115,116,117,118],"herpes zoster","shingles","varicella zoster virus","Virus-Like Particles","vaccine","2025-03-26",{"date":121,"type":122},"2025-04-01","ACTUAL",{"date":124,"type":122},"2025-03-13",{"date":126,"type":106},"2026-10",{"name":5,"class":6},1]