[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spectrum-disease-neuromyelitis-optica\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spectrum-disease-neuromyelitis-optica":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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",false,"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","ALL","18 Years",{"count":19,"type":20},160,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29],"Vaccine","Varicella-zoster Virus","Multiple Sclerosis","Spectrum Disease Neuromyelitis Optica",[31,32,33,34,35,36],"herpes zoster","immunosuppression","anti-CD20 therapy","vaccination","immunogenicity","optimization","NOT_YET_RECRUITING","2026-09-07",{"date":40,"type":41},"2026-09-14","ACTUAL",{"date":43,"type":20},"2026-10-20",{"date":45,"type":20},"2030-11-30",{"name":47,"class":48},"University Hospital, Toulouse","OTHER",24]