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

Sheba Medical Center

Status: Unknown

Conditions: Multiple Sclerosis

Treatments: Biological: COVID-19 vaccination

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05075499

8182-21 SMC

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 3 patient groups

MS no immunomodulatory treatment

Active Comparator group

Description:

MS patients receiving no immunomodulatory treatment

Treatment:

Biological: COVID-19 vaccination

MS Teriflunomide treatment

Active Comparator group

Description:

MS patients under treatment with Teriflunomide

Treatment:

Biological: COVID-19 vaccination

MS Alemtuzumab treatment

Active Comparator group

Description:

MS patients under treatment with Alemtuzumab

Treatment:

Biological: COVID-19 vaccination