RECRUITINGPhase 4INTERVENTIONAL
Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients
Immunogenicity of the Recombinant Zoster Vaccine (Shingrix ®) in Multiple Sclerosis Patients Treated With Anti-CD20 Antibodies Compared to Controls- a Phase IV Monocentric Study
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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
- willing to sign a consent form as documented by signature
For healthy controls
- Aged 50 to 59
- Not already vaccinated by RZV and willing to be vaccinated with RZV
- willing to sign a consent form as documented by signature
Who Should NOT Join This Trial:
- 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 weakened immune system; 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 willing to sign a consent form 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
recombinant zoster vaccine
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
Locations (1)
University Hospitals of Geneva
Geneva, Switzerland