Clinical trial NCT05596526: Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients
Official title: Immunogenicity of the Recombinant Zoster Vaccine (Shingrix ®) in Multiple Sclerosis Patients Treated With Anti-CD20 Antibodies Compared to Controls- a Phase IV Monocentric Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Shingles
Zoster
Keywords: RZV vaccine
Multiple Sclerosis
Immune response
Safety
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: In this monocentric study, we will assess the immunogenicity and safety of two doses of the adjuvanted recombinant Zoster vaccine (RZV, or Shingrix®) in Multiple sclerosis patients treated with anti-CD20 (ocrelizumab, group 1) compared to healthy controls (group 2).

Participants will receive Shingrix® on Day0 and Day60; immunological response will be assessed on Day 0, 1, Day 60, 61, Day90 and Day360.

Unsolicited Adverse events of special interest (AESI) will be collected throughout the study period; patients reported outcomes (PROs) will be declared for one week after each vaccination. Safety of MS patients will be monitored through EDSS scoring and MRI before and 1 month after vaccination (D90) and at day 180 and 360 (EDSS scoring only)

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.

Primary outcomes:
measure: Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG
timeFrame: day 90
Secondary outcomes:
measure: Vaccine safety - AESI 7 days
timeFrame: 7 days
measure: Vaccine safety - SAE 360 days
timeFrame: day 360
measure: Vaccine safety -pIMDs
timeFrame: day 360
measure: Vaccine safety-relapse in MS patients
timeFrame: day 90
measure: Vaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90
timeFrame: Day 90
Other outcomes:
Locations:
city: Geneva,
country: Switzerland
facility: University Hospitals of Geneva
Study officials:
affiliation: University Hospitals of Geneva
name: Patrice Lalive, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospitals of Geneva
name: Arnaud Didierlaurent, Pr
role: STUDY_DIRECTOR
References: