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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
Sponsor: University Hospital, Toulouse
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-10-20
Completion Date
2030-11-30
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
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.
Locations (24)
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