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Clinical Trial Summary

The purpose of this study is to provide evidence as to whether RZV is immunogenic with an acceptable safety profile in Multiple Sclerosis patients on anti-CD20 treatment.


Clinical Trial Description

In this monocentric study, we will assess the immunogenicity and safety of two doses of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in Multiple sclerosis patients treated with anti-CD20 (ocrelizumab, group 1) compared to healthy controls (group 2). Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 0, 1, Day 60, 61, Day90 and Day360. Unsolicited Adverse events of special interest (AESI) will be collected throughout the study period; patients reported outcomes (PROs) will be declared for one week after each vaccination. Safety of MS patients will be monitored through EDSS scoring and MRI before and 1 month after vaccination (D90) and at day 180 and 360 (EDSS scoring only) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05596526
Study type Interventional
Source University Hospital, Geneva
Contact Arnaud Didierlaurent, Pr
Phone +41 22 37 95781
Email arnaud.didierlaurent@hcuge.ch
Status Recruiting
Phase Phase 4
Start date December 1, 2022
Completion date December 31, 2025

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