Testing a shingles 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

This study is testing a shingles vaccine in people with multiple sclerosis who are on a specific treatment to see if it works well and is safe for them.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: University Hospital, Geneva (other)
• Drugs / interventions: Ocrelizumab
• Locations: 1 site (Geneva,)
• Trial ID: NCT05596526 on ClinicalTrials.gov

What this trial studies

This study evaluates the immunogenicity and safety of the recombinant Zoster vaccine (RZV) in patients with multiple sclerosis (MS) who are undergoing treatment with anti-CD20 therapy. Participants will receive two doses of the vaccine, and their immune responses will be monitored at various intervals. The study also includes a control group of healthy individuals for comparison. Safety assessments will be conducted through clinical evaluations and MRI scans at specified time points.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of relapsing multiple sclerosis who have been on anti-CD20 treatment for at least one year.

Not a fit: Patients who have had a recent MS relapse, ongoing infections, or are immunocompromised may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide evidence for the safety and effectiveness of the shingles vaccine in MS patients, potentially reducing their risk of developing shingles.

How similar studies have performed: While there is limited data on the use of RZV in MS patients specifically, similar studies have shown promising results in other populations regarding the vaccine's immunogenicity and safety.

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.

Where this trial is running

Geneva,

• University Hospitals of Geneva — Geneva,, Switzerland (RECRUITING)

Study contacts

• Principal investigator: Patrice Lalive, Pr — University Hospitals of Geneva
• Study coordinator: Arnaud Didierlaurent, Pr

Conditions: Shingles, Zoster, RZV vaccine, Multiple Sclerosis, Immune response, Safety