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Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab

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ClinicalTrials.gov Identifier: NCT05075499
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 12, 2021
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Prof. Anat Achiron, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Biological: COVID-19 vaccination Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: LONGEVITY OF IMMUNE RESPONSE TO COVID-19 VACCINE IN VACCINATED MULTIPLE SCLEROSIS PATIENTS TREATED WITH TERIFLUNOMIDE (AUBAGIO) OR ALEMTUZUMAB (LEMTRADA)
Actual Study Start Date : March 20, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MS no immunomodulatory treatment
MS patients receiving no immunomodulatory treatment
Biological: COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
Other Name: Blood withdrawn

Active Comparator: MS Teriflunomide treatment
MS patients under treatment with Teriflunomide
Biological: COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
Other Name: Blood withdrawn

Active Comparator: MS Alemtuzumab treatment
MS patients under treatment with Alemtuzumab
Biological: COVID-19 vaccination
Blood sample obtained before, 1 , 3 and 6 months after the intervention
Other Name: Blood withdrawn




Primary Outcome Measures :
  1. Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose. [ Time Frame: 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 Outcome Measures :
  1. Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 3 and 6 months post 2nd COVID-19 vaccination. [ Time Frame: 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

  2. SARS-COV-2 antibody titer at 1,3 and 6 months post 2nd COVID-19 vaccination. [ Time Frame: 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

  3. SARS-COV-2 B-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination. [ Time Frame: 12 months ]
    Reversed antigen human IgG SARS-CoV-2 receptor-binding domain (RBD) ELISpotPLUS will be used according to the manufacturer instructions.

  4. 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. [ Time Frame: 12 months ]
    Positive T cell response will be calculated according to the highest number of IFN-γ/IL-2 secreting cells in the FluoroSpot

  5. SARS-COV-2 T-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination. [ Time Frame: 12 months ]
    As indicated in outcome #5

  6. 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. [ Time Frame: 6 months ]
    Statistical analysis

  7. 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. [ Time Frame: 6 months ]
    Statistical analysis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075499


Contacts
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Contact: Anat Achiron, MD, PhD 97235303932 anat.achiron@sheba.health.gov.il
Contact: Sue Mayost, LLB 97235305992 Sue.Mayost@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Shani Tomer    97235303932    Shani.Tomer@sheba.health.gov.il   
Contact: Maria Didikin       Maria.Didikin@sheba.health.gov.il   
Principal Investigator: Anat Achiron, MD, PhD         
Sponsors and Collaborators
Sheba Medical Center
Sanofi
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Study scientific background
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Study scientific background. World Health Organization 2021. Background document on mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Study scientific background.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Study scientific background.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Study scientific background.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Alemtuzumab medication
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Alemtuzumab medication
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Alemtuzumab medication
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Aubagio (teriflunomide) [prescribing information]. Cambridge (MA): Genzyme Corporation; September 2012.
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Aubagio (teriflunomide) medication
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: PMID
Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.

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Responsible Party: Prof. Anat Achiron, Director, Multiple Sclerosis Center, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT05075499    
Other Study ID Numbers: 8182-21 SMC
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 12, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Anat Achiron, Sheba Medical Center:
Multiple sclerosis
COVID-19
Vaccination
Teriflunomide (Aubagio)
Alemtuzumab (Lemtrada)
Immune responses
IgG
B-cells
T-cells
Additional relevant MeSH terms:
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COVID-19
Multiple Sclerosis
Sclerosis
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs