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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MS no immunomodulatory treatment | Active Comparator | MS patients receiving no immunomodulatory treatment |
|
| MS Teriflunomide treatment | Active Comparator | MS patients under treatment with Teriflunomide |
|
| MS Alemtuzumab treatment | Active Comparator | MS patients under treatment with Alemtuzumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| COVID-19 vaccination | Biological | Blood sample obtained before, 1 , 3 and 6 months after the intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose. | 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 3 and 6 months post 2nd COVID-19 vaccination. | 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 | 12months |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anat Achiron, MD, PhD | Contact | 97235303932 | anat.achiron@sheba.health.gov.il | |
| Sue Mayost, LLB | Contact | 97235305992 | Sue.Mayost@sheba.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Recruiting | Ramat Gan | 52621 | Israel |
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| ID | Type | URL | Comment |
|---|---|---|---|
| PMID | Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000719707 | heterologous prime boost COVID-19 vaccination |
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|
| SARS-COV-2 antibody titer at 1,3 and 6 months post 2nd COVID-19 vaccination. |
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 |
| 12 months |
| SARS-COV-2 B-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination. | Reversed antigen human IgG SARS-CoV-2 receptor-binding domain (RBD) ELISpotPLUS will be used according to the manufacturer instructions. | 12 months |
| 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. | Positive T cell response will be calculated according to the highest number of IFN-γ/IL-2 secreting cells in the FluoroSpot | 12 months |
| SARS-COV-2 T-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination. | As indicated in outcome #5 | 12 months |
| 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. | Statistical analysis | 6 months |
| 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. | Statistical analysis | 6 months |
Study scientific background |
| PMID | Study Protocol | View IPD | Study scientific background. World Health Organization 2021. Background document on mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19. |
| PMID | Study Protocol | View IPD | Study scientific background. |
| PMID | Study Protocol | View IPD | Study scientific background. |
| PMID | Study Protocol | View IPD | Study scientific background. |
| PMID | Study Protocol | View IPD | Alemtuzumab medication |
| PMID | Study Protocol | View IPD | Alemtuzumab medication |
| PMID | Study Protocol | View IPD | Alemtuzumab medication |
| PMID | Study Protocol | View IPD | Aubagio (teriflunomide) [prescribing information]. Cambridge (MA): Genzyme Corporation; September 2012. |
| PMID | Study Protocol | View IPD | Aubagio (teriflunomide) medication |
| PMID | Study Protocol | View IPD | Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |