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

Korábbi kezelés

• 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

Más betegség

• Hypersensitivity to the active substance or to one of the excipients
• 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

Egyéb

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

• Patients with Multiple Sclerosis (any clinical form) or Neuromyelitis optica spectrum disease 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