Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients (NCT05596526) | Clinical Trial Compass
UnknownPhase 4
Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients
Switzerland100 participantsStarted 2022-12-01
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (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
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 planned pregnancy in the six months following RZV vaccination
* Immunosuppression 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 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 th…
What they're measuring
1
Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG