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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05019248
Other study ID # 2021-1474
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date April 30, 2022

Study information

Verified date August 2021
Source Heinrich-Heine University, Duesseldorf
Contact Sven G Meuth, MD, PhD
Phone 0049 211 81 19532
Email svenguenther.meuth@med.uni-duesseldorf.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 260
Est. completion date April 30, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
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)).

Locations

Country Name City State
Germany Medical Faculty, Heinrich-Heine-University Duesseldorf Northrhine-Westphalia

Sponsors (1)

Lead Sponsor Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion who achieve seroprotection The capacity of influenza vaccine to elicit a measurable immune response (immunogenicity) when it is administered (i) shortly (at least 4-6 weeks) before cladribine initiation (cohort 1), (ii) 3 to 4 months after cladribine initiation (cohort 2) (iii) shortly (at least 4-6 weeks) before second cladribine administration (cohort 3) and (iv) in patients who have already received the second cycle of cladribine tablets (3 to 4 months after second cycle; cohort 4), compared to RRMS patients treated with basic DMTs (cohort 5). Efficacy is measured as proportion of patients who achieve seroprotection (specific hemagglutination inhibition (HI) titers > 1:40)). 6 months
Secondary Fraction with 2-fold increase of HI titers Proportion of patients who achieve a 2-fold increase in specific HI titers at 6 to 8 months post-immunization 6 months
Secondary Fraction with 4-fold increase of HI titers Proportion of patients who achieve a 4-fold increase in specific HI titers at 6 months post-immunization 6 months
Secondary Seroconversion rate Proportion of patients with seroconversion (i.e., a pre-vaccination antibody titer < 10 and a post-vaccination HI titer > 40) 6 months
Secondary Mean antibody titers Geometric mean antibody titers (GMTs) and geometric mean antibody ratios (GMRs, post-vaccination:pre-vaccination) prior and 6 months after vaccination 6 months
Secondary Cellular immune responses Flow cytometry analysis, which will include (but is not limited to) the following cells: Total B cells (CD19 positive), B-cell subsets, e.g., memory B cells, naïve B cells, plasma cells; Total T cell (CD3 positive) and T cell subsets, e.g. T helper cells, cytotoxic lymphocyte T cells 6 months
Secondary Serum immunoglobulin subtypes Analysis of quantitative Ig levels (including total Ig, IgG, IgG subtypes, IgM, and IgA) 6 months
Secondary Influenza infections Incidence of infections caused by influenza 6 months
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