A Phase 4 interventional study of recombinant zoster vaccine in Shingles and Zoster, sponsored by Prof Patrice Lalive. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Prof Patrice Lalive · Phase 4, Interventional, and Treatment
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.
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)
360 studies on the registry are indexed under Herpes Zoster; 60 are open to participants now.
This study's planned enrollment of 100 is below the median of 250 across 299 interventional studies indexed under Herpes Zoster.
Browse Herpes Zoster studies →This is the only study on the registry with Prof Patrice Lalive as lead sponsor.
Counted across the registry records on this site, refreshed daily.
For MS patients:
For healthy controls
Exclusion Criteria:
Participants aged 18 and above will receive two doses of the recombinant Zoster vaccine (Shingrix®)
Biological: recombinant zoster vaccine
Healthy participants aged 50 to 59 will receive two doses of the recombinant Zoster vaccine (Shingrix®)
Biological: recombinant zoster vaccine
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
Also known as: Shingrix®
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
Time frame: day 90
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
Time frame: 7 days
Vaccine safety - SAE 360 days
Incidence of serious adverse events (SAE) throughout the study period
Time frame: day 360
Vaccine safety -pIMDs
Incidence of potential immune mediated disorders (pIMDs) throughout the study period
Time frame: day 360
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
Time frame: day 90
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
Time frame: Day 90
Plan to share: No
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