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Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients (MSHINGVAX)

Primary Purpose

Shingles, Zoster

Status

Not yet recruiting

Phase

Phase 4

Locations

Switzerland

Study Type

Interventional

Intervention

recombinant zoster vaccine

About this trial

This is an interventional treatment trial for Shingles focused on measuring RZV vaccine, Multiple Sclerosis, Immune response, Safety

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University Hospitals of Geneva

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MS patients on anti-CD20

Healthy controls

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Vaccine safety - SAE 360 days

Incidence of serious adverse events (SAE) throughout the study period

Vaccine safety -pIMDs

Incidence of potential immune mediated disorders (pIMDs) throughout the study period

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

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

Full Information

NCT ID

NCT05596526

First Posted

October 24, 2022

Last Updated

October 24, 2022

Sponsor

Prof Patrice Lalive

1. Study Identification

Unique Protocol Identification Number

NCT05596526

Brief Title

Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2022 (Anticipated)

Primary Completion Date

November 1, 2024 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof Patrice Lalive

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shingles, Zoster

Keywords

RZV vaccine, Multiple Sclerosis, Immune response, Safety

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MS patients on anti-CD20

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy controls

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

recombinant zoster vaccine

Other Intervention Name(s)

Shingrix®

Intervention Description

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

Primary Outcome Measure Information:

Title

Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG

Description

gE-specific total Immunoglobulin(Ig)G titers is determined by gE-specific ELISA from sera samples

Time Frame

day 90

Secondary Outcome Measure Information:

Title

Vaccine safety - AESI 7 days

Description

Incidence adverse events of special interest (AESI) in the 7 days following each vaccination (reactogenicity) collected in a diary card

Time Frame

7 days

Title

Vaccine safety - SAE 360 days

Description

Incidence of serious adverse events (SAE) throughout the study period

Time Frame

day 360

Title

Vaccine safety -pIMDs

Description

Incidence of potential immune mediated disorders (pIMDs) throughout the study period

Time Frame

day 360

Title

Vaccine safety-relapse in MS patients

Description

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

Title

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

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Arnaud Didierlaurent, Pr

Phone

+41 22 37 95781

arnaud.didierlaurent@hcuge.ch

First Name & Middle Initial & Last Name or Official Title & Degree

Patrice Lalive, Pr

Phone

+41 22 3728318

patrice.lalive@hcuge.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrice Lalive, Pr

Organizational Affiliation

University Hospitals of Geneva

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Arnaud Didierlaurent, Pr

Organizational Affiliation

University Hospitals of Geneva

Official's Role

Study Director

Facility Information:

Facility Name

University Hospitals of Geneva

City

Geneva,

ZIP/Postal Code

1205

Country

Switzerland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Arnaud Didierlaurent, Phd

Phone

+41 22 37 95781

arnaud.didierlaurent@unige.ch

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://www.ema.europa.eu/en/documents/product-information/shingrix-epar-product-information_en.pdf

Description

Shingrix vaccine information

Learn more about this trial

Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients

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