Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

Shingles Clinical Trial

— MSHINGVAX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05596526
• Other study ID #: 2022-01255
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Geneva
• Contact: Arnaud Didierlaurent, Pr
• Phone: +41 22 37 95781
• Email: arnaud.didierlaurent[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpes Zoster
• Multiple Sclerosis
• Sclerosis
• Shingles
• Zoster

Intervention

Biological:
• recombinant zoster vaccine
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60

Locations

Country	Name	City	State
Switzerland	University Hospitals of Geneva	Geneva,

Sponsors (1)

Lead Sponsor	Collaborator
Prof Patrice Lalive

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG	gE-specific total Immunoglobulin(Ig)G titers is determined by gE-specific ELISA from sera samples	day 90
Secondary	Vaccine safety - AESI 7 days	Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card	7 days
Secondary	Vaccine safety - SAE 360 days	Incidence of serious adverse events (SAE) throughout the study period	day 360
Secondary	Vaccine safety -pIMDs	Incidence of potential immune mediated disorders (pIMDs) throughout the study period	day 360
Secondary	Vaccine safety-relapse in MS patients	Incidence of relapse in MS patients during a follow-up of 3 months after the first dose (d90) compared to the year preceding vaccination with RZV	day 90
Secondary	Vaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90	Mean of gE-specific CD4+ T cells expressing at least 2 activation markers (i.e. CD40 ligand, interferon-gamma, IL-2 or TNF-alpha) per million of T cells, measured at D90	Day 90

External Links

•   Shingrix vaccine information