Clinical trial NCT05075499: Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Treated With Teriflunomide and Alemtuzumab
Official title: LONGEVITY OF IMMUNE RESPONSE TO COVID-19 VACCINE IN VACCINATED MULTIPLE SCLEROSIS PATIENTS TREATED WITH TERIFLUNOMIDE (AUBAGIO) OR ALEMTUZUMAB (LEMTRADA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
COVID-19
Vaccination
Teriflunomide (Aubagio)
Alemtuzumab (Lemtrada)
Immune responses
IgG
B-cells
T-cells
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Sanofi
First posted: 2021-10-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
measure: Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose.
timeFrame: 6 months
Secondary outcomes:
measure: Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 3 and 6 months post 2nd COVID-19 vaccination.
timeFrame: 12months
measure: SARS-COV-2 antibody titer at 1,3 and 6 months post 2nd COVID-19 vaccination.
timeFrame: 12 months
measure: SARS-COV-2 B-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
measure: SARS-COV-2 T-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination.
timeFrame: 12 months
measure: 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.
timeFrame: 6 months
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: