[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620210":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":11,"centralContacts":49,"locations":11,"responsibleParty":55,"collaborators":11,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":11,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":11,"overallStatus":76,"whyStopped":11,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":11},{"fullName":5,"class":6},"CSPC Megalith Biopharmaceutical Co.,Ltd.","INDUSTRY",[8,14,17,20,23,26,31],{"label":9,"type":10,"description":11,"interventionNames":12},"Dosage A of zoster mRNA vaccine SYS6017","EXPERIMENTAL",null,[13],"Biological: A zoster mRNA vaccine SYS6017",{"label":15,"type":10,"description":11,"interventionNames":16},"Dosage B of zoster mRNA vaccine SYS6017",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"Dosage C of zoster mRNA vaccine SYS6017",[13],{"label":21,"type":10,"description":11,"interventionNames":22},"Dosage D of zoster mRNA vaccine SYS6017",[13],{"label":24,"type":10,"description":11,"interventionNames":25},"Dosage E of zoster mRNA vaccine SYS6017",[13],{"label":27,"type":28,"description":11,"interventionNames":29},"Placebo","PLACEBO_COMPARATOR",[30],"Other: Placebo",{"label":32,"type":33,"description":11,"interventionNames":34},"Active Comparator Vaccine","ACTIVE_COMPARATOR",[35],"Biological: Active Comparator Vaccine",[37,42,46],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"BIOLOGICAL","A zoster mRNA vaccine SYS6017","SYS6017，two-dose vaccination schedule (Month 0, 2)",[9,15,18,21,24],{"type":43,"name":27,"description":44,"armGroupLabels":45,"otherNames":11},"OTHER","0.9% saline，two-dose vaccination schedule (Month 0, 2)",[27],{"type":38,"name":32,"description":47,"armGroupLabels":48,"otherNames":11},"Recombinant Zoster Vaccine (CHO cell)，two-dose vaccination schedule (Month 0, 2)",[32],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Clinical Trials Information Group officer","CONTACT","86-0311-69085587","ctr-contact@cspc.cn",{"type":56,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620210","phase-2-immunogenicity-and-safety-of-sys6017-in-the-participants-aged-40-years-and-above-100620210",false,"NCT07354659","Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above","A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Study to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above","Inclusion Criteria:\n\n* 1\\. Individuals aged 40 years or older;\n* 2\\. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;\n* 3\\. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);\n* 4\\. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.\n\nExclusion Criteria:\n\n* 1\\. History of zoster;\n* 2\\. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);\n* 3\\. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;\n* 4\\. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);\n* 5\\. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that could increases the risk of myocarditis or pericarditis\n* 6\\. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.;\n* 7\\. Current epilepsy or convulsion, severe neurological or psychiatric disorders;\n* 8\\. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or ongoing treatment with anticoagulants, etc.;\n* 9\\. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;\n* 10\\. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;\n* 11\\. History of diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy before enrollment;\n* 12\\. Long-term (defined as more than 14 consecutive days) systemic use of immunosuppressants, immunostimulants, or other immunomodulatory drugs (e.g., corticosteroids at a dose of ≥ 20 mg\u002Fday prednisone or equivalent) within 6 months prior to enrollment; however, inhaled and topical corticosteroids are permitted; or planned administration of the aforementioned agents during the study period;\n* 13\\. Administration of whole blood, plasma, serum, immunoglobulin, or monoclonal antibodies within 3 months prior to enrollment, or planned administration of the aforementioned products during the study period;\n* 14\\. Blood donation or blood loss ≥ 450 mL within one month before enrollment, or planning to donate blood during the study;\n* 15\\. Vaccination with any other vaccines within 30 days prior to enrollment, or planned vaccination with any other vaccines within 30 days after the last dose of the study vaccine;\n* 16\\. Current participation in or planned participation in other clinical trials during the study period;\n* 17\\. For female participants of childbearing potential: positive pregnancy test result prior to enrollment, current pregnancy or lactation, or planned pregnancy within 8 months after enrollment;\n* 18\\. Unable to comply with the study procedures and requirements, or presence of other conditions that make the participant inappropriate for this clinical trial, as judged by the investigators.",true,"ALL","40 Years",{"count":68,"type":69},800,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled \"A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above\".",[75],"Herpes Zoster","NOT_YET_RECRUITING","2026-01-12",{"date":79,"type":80},"2026-01-21","ACTUAL",{"date":82,"type":69},"2026-01-10",{"date":84,"type":69},"2027-05-31",{"name":5,"class":6}]