Loading clinical trials...

Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine | Clinical Trials | Clareo Health

UNKNOWN

Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine

A Non-interventional Observation Study to Evaluate Immune Responses Following Seasonal Influenza Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Cladribine Tablets

NCT05019248•Heinrich-Heine University, Duesseldorf

View on ClinicalTrials.gov

Summary

The primary objective of this study is to characterize the antibody response to seasonal influenza vaccine, in patients with active RRMS, treated with cladribine, compared to control individuals with basic immunomodulatory treatment. Serum antibody titers against the respective pathogen will be assessed prior to and 6 to 8 months following vaccination.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed informed consent form (ICF)
•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

•1. Previous treatment with B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
•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

Locations (1)

Medical Faculty, Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, Germany

Key Dates

Start Date

September 1, 2020

Primary Completion Date

December 31, 2021

Completion Date

April 30, 2022

Last Updated

August 24, 2021

Enrollment

260

ESTIMATED participants

Conditions

Multiple Sclerosis, Relapsing-RemittingVaccine Response Impaired

Interventions

Most recent vaccine to seasonal influenza

BIOLOGICAL

Contacts

Sven G Meuth, MD, PhD

CONTACT

0049 211 81 19532 svenguenther.meuth@med.uni-duesseldorf.de

Leoni Rolfes, MD

CONTACT

0049 211 81 19532 leoni.rolfes@med.uni-duesseldorf.de

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

NCT05359653

Multiple Sclerosis (MS)Multiple Sclerosis, Relapsing-Remitting+5 more

View study

RECRUITINGNA

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

NCT06390930

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immune Response to Seasonal Influenza Vaccination in Multiple Sclerosis Patients Receiving Cladribine

Inclusion Criteria

Exclusion Criteria

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Effects of Acute Intermittent Hypoxia on Neuroplasticity in MS

Retinal Neuro-vascular Coupling in Patients With Multiple Sclerosis

Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients

Light Stimulation to Improve Visual Function After Optic Neuritis in Persons with Multiple Sclerosis

Non-inferiority Study of Rituximab Compared to Ocrelizumab in Relapsing MS