Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vaccination prior to first cladribine exposition |
| ||
| vaccination shortly after first cladribine exposition |
| ||
| vaccination prior to second cladribine exposition |
| ||
| vaccination following completion of cladribine treatment |
| ||
| vaccination in patients with RRMS not subjected to cladribine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Most recent vaccine to seasonal influenza | Biological | Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Fraction with 4-fold increase of HI titers |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
52 patients per group/cohort, resulting in a theoretical maximum number of 260 patients. Patients will be screened until this number is reached.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Sven G Meuth, MD, PhD | Heinrich-Heine-University Duesseldorf, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Faculty, Heinrich-Heine-University | Recruiting | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37174643 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
(I) Serum samples for assessment of antibody levels (II) Peripheral blood mononuclear cells for assessment of cellular immune responses
Proportion of patients who achieve a 4-fold increase in specific HI titers at 6 months post-immunization
| 6 months |
| Seroconversion rate | Proportion of patients with seroconversion (i.e., a pre-vaccination antibody titer < 10 and a post-vaccination HI titer > 40) | 6 months |
| 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 |
| 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 |
| Serum immunoglobulin subtypes | Analysis of quantitative Ig levels (including total Ig, IgG, IgG subtypes, IgM, and IgA) | 6 months |
| Influenza infections | Incidence of infections caused by influenza | 6 months |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |