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NCT07818356Not yet recruitingPhase 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

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.

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Sept 2026

Brief summary (registry, in English)

To compare, in MS and NMOSD patients receiving anti-CD20 mAbs IV or SC every 6 months, the humoral response elicited by a 2-dose RZV vaccine scheduled 2 (M0-M2, “2 months group”, the standard group) or 6 months (M0-M6, “6 months group”, the experimental group) apart and measured 1 month after the second dose. The first dose will be administered 1 month prior to the anti CD20 infusion, and the second either 1 (“2 months group”) or 5 months (“6 months group”) after.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
160 (estimated)
First submitted
17 Apr 2026
Start date
1 Sept 2026
Lead sponsor
Centre Hospitalier Universitaire De Toulouse
EU CT number
2025-525106-37-00

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 160
  • 24 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Temporary contraindication to vaccination (concurrent episode of acute fever >38.5°C)
  • Patients already treated or supposed to be treated with Ofatumumab (another anti-CD20 mAbs but delivered with a monthly subcutaneous injection)
  • 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
  • Patients who have been exposed to Cladribine in the prior 12 months
  • 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

Other illness

  • Criteria related to the use of ancillary anti-CD20 treatments (Rituximab and Ocrelizumab): - Hypersensitivity 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
  • Hypersensitivity to the active substance or to one of the excipients

Other

  • Pregnancy or breast-feeding
  • Women of childbearing potential (WOCBP) without effective contraception throughout the duration of the trial
  • Shingles in the last 12 months or VZV vaccination in the last 5 years
  • Patient protected by the law (guardianship, curatorship)

Who the study is looking for

  • Patients with MS (any clinical form) or NMOSD seropositive for aquaporin-4 antibodies (AQP4+)
  • Aged 18 years or more
  • Treated with anti-CD20 mAbs (Rituximab IV or Ocrelizumab IV or SC) since < 2 years with dosing intervals of 6 months (and for Rituximab, treated with 1g per infusion)
  • 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)
  • Known history in the medical file of varicella, or VZV IgG serology known to evidence a prior infection
  • Affiliated or beneficiary of a social security scheme
  • Written and informed consent
  • Understands and agrees to comply with the study procedures

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Besancon
Coordinator of this site? Confirm its status
Besancon CedexFranceNot yet recruiting
Hospices Civils de Lyon
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BronFranceNot yet recruiting
Centre Hospitalier Universitaire De Caen Normandie
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Caen Cedex 9FranceNot yet recruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceNot yet recruiting
Centre Hospitalier Intercommunal Créteil
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CréteilFranceNot yet recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceNot yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceNot yet recruiting
Centre Hospitalier De Libourne Robert Boulin
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Libourne CedexFranceNot yet recruiting
Groupement Des Hopitaux De L'Institut Catholique De Lille
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LilleFranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire De Nantes
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Nantes Cedex 1FranceNot yet recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceNot yet recruiting
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceNot yet recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceNot yet recruiting
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
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ParisFranceNot yet recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 13FranceNot yet recruiting
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceNot yet recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceNot yet recruiting
Centre Hospitalier Universitaire Rouen
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Rouen CedexFranceNot yet recruiting
Centre Hospitalier Intercommunal De Poissy Saint Germain
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St Germain En Laye CedexFranceNot yet recruiting
Centre Hospitalier Universitaire De Bordeaux
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TalenceFranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceNot yet recruiting
Centre Hospitalier Régional Universitaire de Tours
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ToursFranceNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.