Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients (MSHINGVAX)

Prof Patrice Lalive

Status and phase: Enrolling; Phase 4

Conditions: Shingles; Zoster

Treatments: Biological: recombinant zoster vaccine

Study type: Interventional

Funder types: Other

Identifiers

NCT05596526

2022-01255

Details and patient eligibility

About

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.

Full 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)

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

MS patients on anti-CD20

Experimental group

Description:

Participants aged 18 and above will receive two doses of the recombinant Zoster vaccine (Shingrix®)

Treatment:

Biological: recombinant zoster vaccine

Healthy controls

Experimental group

Description:

Healthy participants aged 50 to 59 will receive two doses of the recombinant Zoster vaccine (Shingrix®)

Treatment:

Biological: recombinant zoster vaccine