[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"varicella-zoster-virus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:varicella-zoster-virus":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100655783","phase-3-phase-iii-clinical-trial-of-lyophilized-herpes-zoster-mrna-vaccine-in-adults-aged-40-years-or-above-100655783",false,"NCT07817108","Phase III Clinical Trial of Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged 40 Years or Above","A Phase III Randomized, Double-blind, Placebo-controlled Trial Evaluating the Vaccine Efficacy, Safety, and Immunogenicity of a Lyophilized Herpes Zoster mRNA Vaccine in Adults Aged ≥40 Years","Inclusion Criteria:\n\n1. Be able and willing to comply with the protocol requirements for all scheduled follow up visits, agree to participate in the trial, and voluntarily sign the ICF approved by EC;\n2. Chinese male or female aged ≥40 year. Participants with underlying medical conditions may be enrolled if their conditions are stably controlled;\n3. Be able to communicate well with the investigator, understand and comply with the protocol requirements for trial participation;\n4. Female participants of childbearing potential and male participants (whose female partners are of childbearing potential) must have practiced effective contraception from the end of the last menstrual cycle of the female participant or partner until the day of vaccination, and must continue to use effective contraception for 6 months after completion of the voluntary vaccination. During this period, they must also refrain from donating sperm or ova. Alternatively, female participants may be considered not of childbearing potential.\n\nExclusion Criteria:\n\n1. Within 3 days prior to vaccination, presence of acute illness, acute exacerbation of chronic disease, or febrile\u002Fnear febrile state, or use of anti inflammatory drugs, antibiotics, antihistamines, or antiviral drugs due to physical discomfort;\n2. On the day of vaccination, for participants aged 40-59 years, systolic blood pressure ≥140 mmHg and\u002For diastolic blood pressure ≥90 mmHg; for participants aged ≥60 years, systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg;\n3. Female participants who are known to be pregnant or breastfeeding, or who have a positive pregnancy test if of childbearing potential;\n4. History of allergy to any component of the investigational vaccine, or history of severe allergic reactions to other vaccines, foods, or drugs;\n5. History of herpes zoster (shingles), history of varicella (chickenpox) within the past year, or close contact with individuals with varicella\u002Fherpes zoster within the past year;\n6. Previous or planned vaccination with herpes zoster or varicella vaccines (including licensed or unlicensed vaccines) during the trial period;\n7. Use of any vaccine within 30 days prior to vaccination, or planned use of any vaccine other than the investigational vaccine within 30 days after administration of the investigational vaccine;\n8. Current participation in another drug or medical device clinical trial within 6 months prior to vaccination, or planned participation in such a trial before the end of this trial;\n9. History of clinically diagnosed coagulation abnormalities or coagulation disorders, or contraindications to intramuscular injection such as receiving anticoagulant therapy;\n10. Known medical history or diagnosis confirming that the participant has or has had a disease affecting immune system function, including malignancies, congenital or acquired immunodeficiencies, autoimmune diseases, or other conditions affecting immune function;\n11. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that increases the risk of myocarditis or pericarditis;\n12. Uncontrolled cardiovascular diseases, severe or uncontrolled respiratory diseases, neurological diseases, hematological and lymphatic diseases, liver and kidney diseases, metabolic and skeletal system diseases, or known severe congenital malformations, developmental disorders, or clinically diagnosed severe chronic diseases that, in the investigator's judgment, may affect the trial results;\n13. Acute infection, acute phase of chronic infection, or currently receiving anti tuberculosis treatment, or those with a previous positive treponemal antibody test;\n14. History or current presence of clearly diagnosed neurological diseases or psychiatric disorders or family history of neurological\u002Fpsychiatric diseases, receipt of facial fillers within 6 months prior to vaccination, and other neurological diseases that the investigator deems unsuitable for participation;\n15. Current skin diseases that, in the investigator's judgment, may affect trial observations;\n16. Use of long term immunosuppressive therapy or other immunomodulatory drugs within 6 months prior to vaccination, or planned use during the period from enrollment to 1 month after the full course of vaccination, with the exception of topical drugs. Topical drugs should not exceed the recommended dose in the package insert or induce signs of systemic exposure. Long term systemic corticosteroids for ≥14 days at a dose of ≥2 mg\u002Fkg\u002Fday or ≥20 mg\u002Fday prednisone or equivalent;\n17. Receipt of immunoglobulins and\u002For blood products, or blood donation, within 3 months prior to vaccination, or planned during the period from enrollment to 1 month after the full course of vaccination;\n18. Suspected or known drug abuse that, in the investigator's opinion, may affect safety evaluation or trial compliance;\n19. Investigators at the trial site\u002Fstudy site, or employees of the sponsor or third party monitoring company involved in the trial;\n20. Other conditions that the investigator deems unsuitable for participation in this trial.",true,"ALL","40 Years",{"count":20,"type":21},18000,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The primary objective of this study is to evaluate the vaccine efficacy, safety and immunogenicity of 2 injections (approximately 2 months apart) of ABO1108 in adults aged 40 years or above.",[27],"Varicella-zoster Virus","RECRUITING","2026-09-08",{"date":31,"type":32},"2026-09-14","ACTUAL",{"date":34,"type":32},"2026-06-27",{"date":36,"type":21},"2027-10-17",{"name":38,"class":39},"Suzhou Abogen Biosciences Co., Ltd.","INDUSTRY",4,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100655794","phase-4-comparative-study-of-two-vaccination-schedules-for-the-subunit-herpes-zoster-vaccine-in-multiple-sclerosis-and-neuromyelitis-optica-spectrum-disease-patients-treated-with-anti-cd20-therapy-an-open-label-randomised-controlled-trial-100655794","NCT07818356","Comparative Study of Two Vaccination Schedules for the Subunit Herpes Zoster Vaccine in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disease Patients Treated With Anti-CD20 Therapy: an Open-label Randomised Controlled Trial","TACTIC","Inclusion Criteria:\n\n* Patients with Multiple Sclerosis (any clinical form) or Neuromyelitis optica spectrum disease seropositive for aquaporin-4 antibodies (AQP4+)\n* Aged 18 years or more\n* Treated with anti-CD20 mAbs (Rituximab IV or Ocrelizumab IV or SC) since \\\u003C 2 years with dosing intervals of 6 months (and for Rituximab, treated with 1g per infusion)\n* Planned to receive the same anti-CD20 mAbs with dosing intervals of 6 months during the 13 months of the study (and for Rituximab, planned to receive 1g per infusion)\n* Known history in the medical file of varicella, or VZV IgG serology known to evidence a prior infection\n* Affiliated or beneficiary of a social security scheme\n* Written and informed consent\n* Understands and agrees to comply with the study procedures\n\nExclusion Criteria:\n\n* Temporary contraindication to vaccination (concurrent episode of acute fever \\>38.5°C)\n* Shingles in the last 12 months or VZV vaccination in the last 5 years\n* Patients already treated or supposed to be treated with Ofatumumab (another anti-CD20 mAbs but delivered with a monthly subcutaneous injection)\n* Patients who received high dose corticosteroids (methylprednisolone at a dose of ≥ 500 mg, administered over 1 to 5 days) in the 3 months prior to inclusion\n* Patients who have been exposed to Cladribine in the prior 12 months\n* Patients who received or were scheduled to receive any vaccination, except for influenza and SARS-CoV-2 vaccines during the epidemic season, within 2 weeks prior to the 2 RZV injections and up to 4 weeks after the second RZV injection\n* Hypersensitivity to the active substance or to one of the excipients\n* Patient protected by the law (guardianship, curatorship)\n* Pregnancy or breast-feeding\n* Women of childbearing potential (WOCBP) without effective contraception throughout the duration of the trial\n* Criteria related to the use of ancillary anti-CD20 treatments (Rituximab and Ocrelizumab):\n\nHypersensitivity to the active substance or to any of the excipients Severe, active infections Severe immunodeficiency Severe heart failure or severe uncontrolled heart disease Known progressive malignancies","18 Years",{"count":50,"type":21},160,[52],"PHASE4","Immunocompromised individuals, such as patients with multiple sclerosis (MS) or diseases of the neuromyelitis optica spectrum (NMOSD) treated with an anti-CD20 monoclonal antibody, present an increased risk of shingles. The immunogenicity - and therefore the clinical effectiveness - of the recombinant vaccine against the varicella zoster virus based on glycoprotein E, recently recommended according to two-dose schedule two months apart in immunocompromised patients aged ≥ 18 years, could be significantly decreased when administered one month before and one month after the infusion of anti-CD20.\n\nWe hypothesize that, in patients with MS or NMOSD treated with anti-CD20 administered every six months, a two-dose M0-M6 vaccination schedule consisting of deferring the second dose six months after the first infusion, that is, five months after the anti-CD20 infusion, could improve vaccine immunogenicity and, consequently, the effectiveness of the vaccine.",[55,27,56,57],"Vaccine","Multiple Sclerosis","Spectrum Disease Neuromyelitis Optica",[59,60,61,62,63,64],"herpes zoster","immunosuppression","anti-CD20 therapy","vaccination","immunogenicity","optimization","NOT_YET_RECRUITING","2026-09-07",{"date":31,"type":32},{"date":69,"type":21},"2026-10-20",{"date":71,"type":21},"2030-11-30",{"name":73,"class":74},"University Hospital, Toulouse","OTHER",24]