Multiple Sclerosis
Conditions
Keywords
Multiple sclerosis, COVID-19, Vaccination, Teriflunomide (Aubagio), Alemtuzumab (Lemtrada), Immune responses, IgG, B-cells, T-cells
Brief summary
Phase IV, 3-armed, prospective, open-label, single-center, Israeli study, examining the response to SARS-CoV-2 vaccination in 30 teriflunomide-, 10 alemtuzumab-treated patients, and 30 age-matched (for the teriflunomide group) untreated MS patients. Treatments will be administered according to common local practice. Demographic, clinical, treatment-related and COVID-19-related data will be collected. Blood samples will be drawn for each participant at baseline (before COVID-19 vaccination), and at 1, 3, 6, (and possibly 12) months post 2nd dose of COVID-19 vaccine. Humoral, B-cell and T-cell responses will be evaluated.
Interventions
BIOLOGICALCOVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
Sponsors
Sanofi
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) Diagnosis of multiple sclerosis (MS) according to 2017 McDonald criteria. (2) Age \>=18 years. (3) Treatment with Teriflunomide for at least 6 months/or 4 to 18 months after the last course treatment with Alemtuzumab/or untreated. (4) Signed written informed consent.
Exclusion criteria
(1) Cognitive decline that precludes understanding the study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose. | 6 months | Detection of SARS-CoV-2 IgG antibodies in blood samples will be performed using Euroimmun (EI, Lubeck, Germany) anti-SARS-CoV-2 IgG quantitative ELISA kit based on a recombinant S1 subunit of the SARS-CoV-2 spike protein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SARS-COV-2 antibody titer at 1,3 and 6 months post 2nd COVID-19 vaccination. | 12 months | Detection of SARS-CoV-2 IgG antibodies in blood samples will be performed using Euroimmun (EI, Lubeck, Germany) anti-SARS-CoV-2 IgG quantitative ELISA kit based on a recombinant S1 subunit of the SARS-CoV-2 spike protein |
| SARS-COV-2 B-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination. | 12 months | Reversed antigen human IgG SARS-CoV-2 receptor-binding domain (RBD) ELISpotPLUS will be used according to the manufacturer instructions. |
| Percent of MS COVID-19 vaccinees with SARS-COV-2 T-cell memory positive response at 1,3 and 6 months post 2nd COVID-19 vaccination. | 12 months | Positive T cell response will be calculated according to the highest number of IFN-γ/IL-2 secreting cells in the FluoroSpot |
| Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 3 and 6 months post 2nd COVID-19 vaccination. | 12months | Detection of SARS-CoV-2 IgG antibodies in blood samples will be performed using Euroimmun (EI, Lubeck, Germany) anti-SARS-CoV-2 IgG quantitative ELISA kit based on a recombinant S1 subunit of the SARS-CoV-2 spike protein |
| Percent of MS COVID-19 vaccinees with positive double immune response (two responses of the possible three), or positive triple immune response (IgG, T-cell and B-cell memory positive) at 6 months post 2nd COVID-19 vaccination. | 6 months | Statistical analysis |
| Percent of MS COVID-19 vaccinees with SARS-COV-2 B-cell memory positive response at 1,3 and 6 months post 2nd COVID-19 vaccination. Positive cut-off value will be determined as higher than 10 SFU. | 6 months | Statistical analysis |
| SARS-COV-2 T-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination. | 12 months | As indicated in outcome #5 |
Countries
Israel
Contacts
Primary ContactAnat Achiron, MD, PhD
Backup ContactSue Mayost, LLB
Outcome results
None listed