Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

Last updated: April 8, 2024
Sponsor: Prof Patrice Lalive
Overall Status: Active - Recruiting

Phase

4

Condition

Shingles

Herpes Simplex Infections

Memory Loss

Treatment

recombinant zoster vaccine

Clinical Study ID

NCT05596526
2022-01255
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 (2weeks apart), one infusion of Ocrelizumab 600 mg 6 months apart, one infusion ofOcrelizumab 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

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 plannedpregnancy in the six months following RZV vaccination
  • Immunosuppression from the following: HIV infection, current active systemicauto-immune disease (other than MS), current malignant neoplasm; primaryimmunodeficiency; recent solid or bone-marrow transplant or any transplant stillrequiring immunosuppressive therapy; conditions requiring medication withimmunosuppressive 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 precedingand during the present study.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: recombinant zoster vaccine
Phase: 4
Study Start date:
December 01, 2022
Estimated Completion Date:
December 31, 2025

Study 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)

Connect with a study center

  • University Hospitals of Geneva

    Geneva,, 1205
    Switzerland

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.