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

NCT07818356 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Toulouse

Phase

Phase 4

Started

2026-10-20

Last updated

2026-09-14

Condition(s) studied

VaccineVaricella-zoster VirusMultiple SclerosisSpectrum Disease Neuromyelitis Optica

Investigational drug(s) / intervention(s)

Two-dose M0-M2 vaccination scheduleTwo-dose M0-M6 vaccination schedule

Two-dose M0-M2 vaccination schedule: Patients randomized to the "2 months" vaccination group will receive their first dose of RZV vaccine one month before the next scheduled infusion anti-CD20 monoclonal antibody (M0 corresponding to the visit during the first dose of vaccine, M1 at the time of scheduled anti-CD20 infusion). The second dose of RZV vaccine will be administered 2 months later. Patients will receive their regular anti-CD20 infusions at times M1, M7, and M13.

Two-dose M0-M6 vaccination schedule: Patients randomized to the "6 months" vaccination group will receive their first dose of RZV vaccine one month before the next scheduled infusion anti-CD20 monoclonal antibody (M0 corresponding to the visit during the first dose of vaccine, M1 at the time of scheduled anti-CD20 infusion). The second dose of RZV vaccine will be administered 6 months later. Patients will receive their regular anti-CD20 infusions at times M1, M7, and M13.

Study summary

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.

We 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 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 Exclusion Criteria: * Temporary contraindication to vaccination (concurrent episode of acute fever \>38.5°C) * Shingles in the last 12 months or VZV vaccination in the last 5 years * 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 * Hypersensitivity to the active substance or to one of the excipients * 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 * 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

Primary outcome measure(s)

Humoral vaccine response rate for IgG anti-VZV gE response — 3 months for the " 2 months " group and 7 months for the " 6 months " group
It will be defined as the proportion of patients with at least a 4-fold increase in anti-VZV gE antibody titers (measured by ELISA) at 1 month after the 2nd vaccine dose compared to baseline (M0), or seroconversion for those who were seronegative at M0.

Trial sites (24)

Facility	City	Region
Jean Minjoz University Hospital	Besançon	France
Pellegrin Hospital Group	Bordeaux	France
Côte de Nacre University Hospital	Caen	France
Gabriel Montpied Hospital	Clermont-Ferrand	France
GCS CHIC Henri Mondor	Créteil	France
Dijon Hospital University	Dijon	France
Nord Hospital - Grenoble University Hospital	Grenoble	France
Libourne Hospital Center	Libourne	France
Roger Salengro Hospital - Lille University Hospital	Lille	France
Catholics Institut Hospitals Group	Lille	France
Lyon Civil Hospices	Lyon	France
Gui de Chauliac Hospital - Montpellier University Hospital	Montpellier	France
Laennec Hospital	Nantes	France
Pasteur Hospital	Nice	France
Nimes University Hospital	Nîmes	France
15/20 Hospital	Paris	France
Pitié Salpetrière Hospital	Paris	France
Adolphe de Rothschild Hospital	Paris	France
Intercommunal Hospital Center of Poissy Saint-Germain	Poissy	France
La Miletrie University Hospital	Poitiers	France
Pontchaillou Hospital	Rennes	France
Charles Nicolle Hospital	Rouen	France
Purpan Hospital	Toulouse	France
Tours Hospital University	Tours	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07818356 on ClinicalTrials.gov ↗ ← All trials in France