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
Sites (24)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Not yet recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Not yet recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Not yet recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes Coordinator of this site? Confirm its status | Grenoble Cedex 9 | France | Not yet recruiting |
| Centre Hospitalier De Libourne Robert Boulin Coordinator of this site? Confirm its status | Libourne Cedex | France | Not yet recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Nantes Coordinator of this site? Confirm its status | Nantes Cedex 1 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier National d'Ophtalmologie des Quize-Vingts Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| Centre Hospitalier Universitaire Rouen Coordinator of this site? Confirm its status | Rouen Cedex | France | Not yet recruiting |
| Centre Hospitalier Intercommunal De Poissy Saint Germain Coordinator of this site? Confirm its status | St Germain En Laye Cedex | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Bordeaux Coordinator of this site? Confirm its status | Talence | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Centre Hospitalier Régional Universitaire de Tours Coordinator of this site? Confirm its status | Tours | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.