Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

NCT05596526 | Recruiting Phase 4

• 1 other identifier: 2022-01255
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Shingles; Zoster

Keywords

RZV vaccine; Multiple Sclerosis; Immune response; Safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Vaccine safety - AESI 7 days

  7 days

• Vaccine safety - SAE 360 days

  day 360

• Vaccine safety -pIMDs

  day 360

• Vaccine safety-relapse in MS patients

  day 90

• Vaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90

  Day 90

Study Arms (2)

MS patients on anti-CD20

EXPERIMENTAL

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

Biological: recombinant zoster vaccine

Healthy controls

EXPERIMENTAL

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

Biological: recombinant zoster vaccine

Interventions

recombinant zoster vaccine BIOLOGICAL

Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60

Also known as: Shingrix®

Healthy controls; MS patients on anti-CD20

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For MS patients:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof Patrice Lalive: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1205, Switzerland

RECRUITING

Related Links

• Shingrix vaccine information

MeSH Terms

Conditions

Herpes Zoster; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Patrice Lalive, Pr

  University Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

• Arnaud Didierlaurent, Pr

  University Hospitals of Geneva

  STUDY DIRECTOR

Central Study Contacts

Arnaud Didierlaurent, Pr

CONTACT

+41 22 37 95781; arnaud.didierlaurent@hcuge.ch

Patrice Lalive, Pr

CONTACT

+41 22 3728318; patrice.lalive@hcuge.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)