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

October 6, 2021 updated by: Prof. Anat Achiron, Sheba Medical Center

LONGEVITY OF IMMUNE RESPONSE TO COVID-19 VACCINE IN VACCINATED MULTIPLE SCLEROSIS PATIENTS TREATED WITH TERIFLUNOMIDE (AUBAGIO) OR ALEMTUZUMAB (LEMTRADA)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Blood withdrawn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
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.
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
12months
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
12 months
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.
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.
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
12 months
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
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.
Time Frame: 6 months
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.
Time Frame: 6 months
Statistical analysis
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

September 1, 2022

Study Registration Dates

First Submitted

October 6, 2021

First Submitted That Met QC Criteria

October 6, 2021

First Posted (Actual)

October 12, 2021

Study Record Updates

Last Update Posted (Actual)

October 12, 2021

Last Update Submitted That Met QC Criteria

October 6, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8182-21 SMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol
    Information identifier: PMID
    Information comments: Study scientific background
  2. Study Protocol
    Information identifier: PMID
    Information comments: Study scientific background. World Health Organization 2021. Background document on mRNA vaccine BNT162b2 (Pfizer-BioNTech) against COVID-19.
  3. Study Protocol
    Information identifier: PMID
    Information comments: Study scientific background.
  4. Study Protocol
    Information identifier: PMID
    Information comments: Study scientific background.
  5. Study Protocol
    Information identifier: PMID
    Information comments: Study scientific background.
  6. Study Protocol
    Information identifier: PMID
    Information comments: Alemtuzumab medication
  7. Study Protocol
    Information identifier: PMID
    Information comments: Alemtuzumab medication
  8. Study Protocol
    Information identifier: PMID
    Information comments: Alemtuzumab medication
  9. Study Protocol
    Information identifier: PMID
    Information comments: Aubagio (teriflunomide) [prescribing information]. Cambridge (MA): Genzyme Corporation; September 2012.
  10. Study Protocol
    Information identifier: PMID
    Information comments: Aubagio (teriflunomide) medication
  11. Study Protocol
    Information identifier: PMID
    Information comments: Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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