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Not Yet Recruiting
NCT05596526
Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients
Conditions: Shingles, Zoster
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: PHASE4
Enrollment: 100
Sponsor: Prof Patrice Lalive
Location: Switzerland
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 Criteria
Inclusion Criteria:For MS patients:18 years and aboveDiagnosed 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 infusionsInformed consent as documented by signatureFor healthy controlsAged 50 to 59Not already vaccinated by RZV and willing to be vaccinated with RZVInformed consent as documented by signatureExclusion Criteria:Recent MS relapse in the 6 weeks preceding planned vaccinationOngoing signs of febrile or non-febrile infection at the time of vaccinationRecent pregnancy with delivery in the six months preceding vaccination and/or planned pregnancy in the six months following RZV vaccinationImmunosuppression from the following: HIV infection, current active systemic auto-immune disease (other than MS), current malignant neoplasm; primary immunodeficiency; recent solid or bone-marrow transplant or any transplant still requiring immunosuppressive therapy; conditions requiring medication with immunosuppressive drugsHaving received a vaccine in the last monthHaving received a shingles vaccine within one yearPresented with herpes zoster in the previous yearContra-indication to RZVUnable 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 preceding and during the present study.
Source: ClinicalTrials.gov (NCT05596526). StuddyBuddy aggregates publicly available trial information.