Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

Launched by PROF PATRICE LALIVE · Oct 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a vaccine called the Recombinant Zoster Vaccine (RZV) in patients with Multiple Sclerosis (MS) who are receiving a specific treatment. The goal is to see if this vaccine can help boost the immune system against shingles, a painful skin condition caused by the same virus that causes chickenpox. The trial is currently looking for participants aged 18 and older with relapsing MS who have been on anti-CD20 treatment for at least a year and have not received the RZV vaccine before. Additionally, healthy individuals aged 50 to 59 who have not been vaccinated with RZV can also join the study.

Participants in the trial will receive the RZV vaccine and will be monitored for any side effects or reactions. Before joining, individuals will need to provide written consent and meet specific health criteria, which means some people may not qualify. It's important to note that those who have had a recent MS relapse, certain infections, or specific medical conditions may be excluded from the study. Overall, this trial aims to gather important information about how well the vaccine works in MS patients and whether it is safe for them to receive it.

Gender

ALL

Eligibility 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.