Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis
Immunogenicity of the Recombinant Zoster Vaccine (Shingrix ®) in Multiple Sclerosis Patients Treated With Anti-CD20 Antibodies Compared to Controls- a Phase IV Monocentric Study
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Varicella zoster virus envelope glycoprotein e
Envelope glycoprotein E vaccine antigen
What it measured
Main measures
Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG
day 90
Other measures (5)
Vaccine safety - AESI 7 days
7 days
SafetyVaccine safety - SAE 360 days
day 360
SafetyVaccine safety -pIMDs
day 360
SafetyVaccine safety-relapse in MS patients
day 90
RelapsesSafetyVaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90
Day 90
Immune response
Who could take part
Relapsing MS · 18 to 60
Show the full criteria
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 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Dec 2022
Main results due
Dec 2024
Finished
Dec 2025