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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS patients on anti-CD20 | Experimental | Participants aged 18 and above will receive two doses of the recombinant Zoster vaccine (Shingrix®) |
|
| Healthy controls | Experimental | Healthy participants aged 50 to 59 will receive two doses of the recombinant Zoster vaccine (Shingrix®) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant zoster vaccine | Biological | Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Vaccine safety - SAE 360 days |
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Inclusion Criteria:
For MS patients:
For healthy controls
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arnaud Didierlaurent, Pr | Contact | +41 22 37 95781 | arnaud.didierlaurent@hcuge.ch | |
| Patrice Lalive, Pr | Contact | +41 22 3728318 | patrice.lalive@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Patrice Lalive, Pr | University Hospitals of Geneva | Principal Investigator |
| Arnaud Didierlaurent, Pr | University Hospitals of Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Geneva | Recruiting | Geneva | 1205 | Switzerland |
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| Label | URL |
|---|---|
| Shingrix vaccine information | View source |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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|
Incidence of serious adverse events (SAE) throughout the study period
| day 360 |
| Vaccine safety -pIMDs | Incidence of potential immune mediated disorders (pIMDs) throughout the study period | 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 | 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 | Day 90 |
| D007239 | Infections |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |