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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
University Hospitals of Geneva
Geneva, Switzerland
RECRUITINGGeometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG
gE-specific total Immunoglobulin(Ig)G titers is determined by gE-specific ELISA from sera samples
Time frame: day 90
Vaccine safety - AESI 7 days
Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card
Time frame: 7 days
Vaccine safety - SAE 360 days
Incidence of serious adverse events (SAE) throughout the study period
Time frame: day 360
Vaccine safety -pIMDs
Incidence of potential immune mediated disorders (pIMDs) throughout the study period
Time frame: day 360
Vaccine safety-relapse in MS patients
Incidence of relapse in MS patients during a follow-up of 3 months after the first dose (d90) compared to the year preceding vaccination with RZV
Time frame: day 90
Vaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90
Mean of gE-specific CD4+ T cells expressing at least 2 activation markers (i.e. CD40 ligand, interferon-gamma, IL-2 or TNF-alpha) per million of T cells, measured at D90
Time frame: Day 90
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