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

Sponsor

Sheba Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05075499

Collaborator

Sanofi (Industry)

Enrollment

Location

Arms

17.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Mar 20, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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COVID-19 vaccination Blood sample obtained before, 1 , 3 and 6 months after the intervention Other Names: Blood withdrawn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COVID-19 vaccination Blood sample obtained before, 1 , 3 and 6 months after the intervention Other Names: Blood withdrawn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COVID-19 vaccination Blood sample obtained before, 1 , 3 and 6 months after the intervention Other Names: Blood withdrawn

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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
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