Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine
NCT ID: NCT05019248
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
260 participants
OBSERVATIONAL
2020-09-01
2022-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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vaccination prior to first cladribine exposition
Most recent vaccine to seasonal influenza
Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
vaccination shortly after first cladribine exposition
Most recent vaccine to seasonal influenza
Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
vaccination prior to second cladribine exposition
Most recent vaccine to seasonal influenza
Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
vaccination following completion of cladribine treatment
Most recent vaccine to seasonal influenza
Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
vaccination in patients with RRMS not subjected to cladribine
Most recent vaccine to seasonal influenza
Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
Interventions
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Most recent vaccine to seasonal influenza
Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
Eligibility Criteria
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Inclusion Criteria
2. Age 18 to 60 years old (inclusive) as of the date the ICF is signed
3. Diagnosis of RRMS according to the revised McDonald criteria
4. EDSS score of 0.0 to 7.0 (inclusive)
5. In case of participants who are subjected to influenza vaccination by the treating physicians prior to cladribine the first or second cycle of cladribine (cohort 1 + cohort 3), this should be performed at least 4 to 6 weeks before the start of cladribine.
Definition of control group:
Patients with active RRMS treated with cladribine will be compared to sex and age matched control individuals, with RRMS under basic treatment either with interferon beta, glatiramer acetate, dimethyl fumarate or teriflunomide, who provide sample material prior to and 6 to 8 months after routine seasonal influenza vaccination during the same period.
Exclusion Criteria
2. Any previous treatment with alemtuzumab, cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
3. Medical, psychiatric, cognitive, or other conditions that, in the investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, or to complete the study
4. Patients that receive immunosuppressive treatment for diseases other than MS or that receive long-term corticosteroid treatment
5. Patients that received apheresis procedures 6 weeks prior to vaccination or in-between vaccination and DMT initiation
6. Systemic high dose corticosteroid therapy within 6 weeks prior to vaccination or in-between vaccination and DMT initiation
7. Patients with verified infection by human-immunodeficiency-virus or hepatitis-c-virus
8. Patients with major impairment of the blood coagulation system including therapy with anticoagulants
9. Patients with known chicken egg allergy
18 Years
60 Years
ALL
No
Sponsors
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Heinrich-Heine University, Duesseldorf
OTHER
Responsible Party
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Principal Investigators
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Sven G Meuth, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Heinrich-Heine-University Duesseldorf, Germany
Locations
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Medical Faculty, Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Rolfes L, Pfeuffer S, Skuljec J, He X, Su C, Oezalp SH, Pawlitzki M, Ruck T, Korsen M, Kleinschnitz K, Aslan D, Hagenacker T, Kleinschnitz C, Meuth SG, Pul R. Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine. Cells. 2023 Apr 25;12(9):1243. doi: 10.3390/cells12091243.
Other Identifiers
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2021-1474
Identifier Type: -
Identifier Source: org_study_id
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