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
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

⁃ For MS patients:

• 18 years and above

• Diagnosed with relapsing MS according to McDonald Criteria (2017)

• Not already vaccinated by RZV and willing to be vaccinated with RZV.

• At least 1 year on anti-CD20 treatment: 2 initial infusions of Ocrelizumab 300 mg (2 weeks apart), one infusion of Ocrelizumab 600 mg 6 months apart, one infusion of Ocrelizumab 600 mg 12 months after initial infusions

• Informed consent as documented by signature

⁃ For healthy controls

• Aged 50 to 59

• Not already vaccinated by RZV and willing to be vaccinated with RZV

• Informed consent as documented by signature

Locations
Other Locations
Switzerland
University Hospitals of Geneva
RECRUITING
Geneva
Contact Information
Primary
Arnaud Didierlaurent, Pr
arnaud.didierlaurent@hcuge.ch
+41 22 37 95781
Backup
Patrice Lalive, Pr
patrice.lalive@hcuge.ch
+41 22 3728318
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: MS patients on anti-CD20
Participants aged 18 and above will receive two doses of the recombinant Zoster vaccine (Shingrix®)
Experimental: Healthy controls
Healthy participants aged 50 to 59 will receive two doses of the recombinant Zoster vaccine (Shingrix®)
Related Therapeutic Areas
Sponsors
Leads: Prof Patrice Lalive

This content was sourced from clinicaltrials.gov