Last updated: April 8, 2024
Sponsor: Prof Patrice Lalive
Overall Status: Active - Recruiting
Phase
4
Condition
Shingles
Herpes Simplex Infections
Memory Loss
Treatment
recombinant zoster vaccine
Clinical Study ID
NCT05596526
2022-01255
Ages 18-60 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: 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 (2weeks apart), one infusion of Ocrelizumab 600 mg 6 months apart, one infusion ofOcrelizumab 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
Exclusion
Exclusion Criteria:
- Recent MS relapse in the 6 weeks preceding planned vaccination
- Ongoing signs of febrile or non-febrile infection at the time of vaccination
- Recent pregnancy with delivery in the six months preceding vaccination and/or plannedpregnancy in the six months following RZV vaccination
- Immunosuppression from the following: HIV infection, current active systemicauto-immune disease (other than MS), current malignant neoplasm; primaryimmunodeficiency; recent solid or bone-marrow transplant or any transplant stillrequiring immunosuppressive therapy; conditions requiring medication withimmunosuppressive drugs
- Having received a vaccine in the last month
- Having received a shingles vaccine within one year
- Presented with herpes zoster in the previous year
- Contra-indication to RZV
- Unable to provide informed consent or inability to follow the procedures of the study,e.g. due to language problems, psychological disorders, dementia.
- Participation in another study with investigational drug within the 30 days precedingand during the present study.
Study Design
Total Participants: 100
Treatment Group(s): 1
Primary Treatment: recombinant zoster vaccine
Phase: 4
Study Start date:
December 01, 2022
Estimated Completion Date:
December 31, 2025
Study Description
Connect with a study center
University Hospitals of Geneva
Geneva,, 1205
SwitzerlandActive - Recruiting
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