ShinglesPhase 4MSHINGVAXNCT05596526
Immunogenicity of the Recombinant Zoster Vaccine in Multiple Sclerosis Patients
A Phase 4 study testing recombinant zoster vaccine in people with Shingles and Zoster, run by Prof Patrice Lalive at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- recombinant zoster vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2022to 31 Dec 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospitals of Geneva
Geneva, 1205
Arnaud Didierlaurent, Phd, +41 22 37 95781, arnaud.didierlaurent@unige.ch
About this study
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
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.
Read the 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)
- Being tested
- recombinant zoster vaccine
- Keywords
- RZV vaccine, Multiple Sclerosis, Immune response, Safety
- Medical subject headings
- Herpes Zoster, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant zoster vaccineBiological
Also called Shingrix®
Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60
| Study group | Role | What they receive |
|---|---|---|
| MS patients on anti-CD20 | Experimental | Participants aged 18 and above will receive two doses of the recombinant Zoster vaccine (Shingrix®) Receives: Biological: recombinant zoster vaccine |
| Healthy controls | Experimental | Healthy participants aged 50 to 59 will receive two doses of the recombinant Zoster vaccine (Shingrix®) Receives: Biological: recombinant zoster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 90
Secondary outcomes (5)
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
Measured: 7 days
Vaccine safety - SAE 360 days
Incidence of serious adverse events (SAE) throughout the study period
Measured: day 360
Vaccine safety -pIMDs
Incidence of potential immune mediated disorders (pIMDs) throughout the study period
Measured: 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
Measured: 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
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Dec 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShinglesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof Patrice Lalive
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof Patrice Lalive, University Hospital, Geneva
- Investigators
- Patrice Lalive, Pr, Principal investigator, University Hospitals of GenevaArnaud Didierlaurent, Pr, Study director, University Hospitals of Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596526
- Sponsor's protocol ID
- 2022-01255
- Acronym
- MSHINGVAX
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05596526
- Acronym / sponsor ID
- MSHINGVAX / 2022-01255
- Keywords
- RZV vaccine, Multiple Sclerosis, Immune response, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Prof Patrice LaliveUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS patients on anti-CD20 | Experimental | Biological: recombinant zoster vaccineParticipants aged 18 and above will receive two doses of the recombinant Zoster vaccine (Shingrix®) |
| Healthy controls | Experimental | Biological: recombinant zoster vaccineHealthy participants aged 50 to 59 will receive two doses of the recombinant Zoster vaccine (Shingrix®) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant zoster vaccineAlso: Shingrix®Shingrix® vaccine will be administered in two vaccinations on Day0 and Day60 | Biological | Healthy controls, MS patients on anti-CD20 |
Primary outcome
Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG
Time frame: day 90
gE-specific total Immunoglobulin(Ig)G titers is determined by gE-specific ELISA from sera samples
5 secondary outcomes
Vaccine safety - AESI 7 days
Time frame: 7 days
Vaccine safety - SAE 360 days
Time frame: day 360
Vaccine safety -pIMDs
Time frame: day 360
Vaccine safety-relapse in MS patients
Time frame: day 90
Vaccine immunogenicity - CD4+ T cells per million of T cells, measured at D90
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Shingrix vaccine informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice Lalive, Pr principal investigator
University Hospitals of Geneva
Arnaud Didierlaurent, Pr study director
University Hospitals of Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing recombinant zoster vaccine in people with Shingles and Zoster, run by Prof Patrice Lalive at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Didierlaurent, Pr (+41 22 37 95781, arnaud.didierlaurent@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer (GMT) of glycoprotein E (gE)-specific total IgG (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.