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NOT YET RECRUITING
NCT07818356
PHASE4

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

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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