NCT05596526

Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

Immunogenicity of the Recombinant Zoster Vaccine (Shingrix ®) in Multiple Sclerosis Patients Treated With Anti-CD20 Antibodies Compared to Controls- a Phase IV Monocentric Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Prof Patrice Lalive · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed 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)

Conditions

• Shingles
• Zoster

Interventions

Type	Name	Description
BIOLOGICAL	recombinant zoster vaccine	Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60

Timeline

• Start date: 2022-12-01
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-10-27
• Last updated: 2024-04-10

Locations

1 site across 1 country: Switzerland