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

NCT05075499 | Unknown

• 1 other identifier: 8182-21 SMC
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; COVID-19; Vaccination; Teriflunomide (Aubagio); Alemtuzumab (Lemtrada); Immune responses; IgG; B-cells; T-cells

Outcome Measures

Primary Outcomes (1)

• Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 1-month post 2nd COVID-19 vaccine dose.

  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 Outcomes (7)

• Percent of SARS-COV-2 antibody positive MS COVID-19 vaccinees at 3 and 6 months post 2nd COVID-19 vaccination.

  12months

• SARS-COV-2 antibody titer at 1,3 and 6 months post 2nd COVID-19 vaccination.

  12 months

• SARS-COV-2 B-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination.

  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.

  12 months

• SARS-COV-2 T-cell memory response at 1,3 and 6 months post 2nd COVID-19 vaccination.

  12 months

Study Arms (3)

MS no immunomodulatory treatment

ACTIVE COMPARATOR

MS patients receiving no immunomodulatory treatment

Biological: COVID-19 vaccination

MS Teriflunomide treatment

ACTIVE COMPARATOR

MS patients under treatment with Teriflunomide

Biological: COVID-19 vaccination

MS Alemtuzumab treatment

ACTIVE COMPARATOR

MS patients under treatment with Alemtuzumab

Biological: COVID-19 vaccination

Interventions

COVID-19 vaccination BIOLOGICAL

Blood sample obtained before, 1 , 3 and 6 months after the intervention

Also known as: Blood withdrawn

MS Alemtuzumab treatment; MS Teriflunomide treatment; MS no immunomodulatory treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (1) Cognitive decline that precludes understanding the study procedures.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Sanofi: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19

Interventions

heterologous prime boost COVID-19 vaccination

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Anat Achiron, MD, PhD

CONTACT

97235303932; anat.achiron@sheba.health.gov.il

Sue Mayost, LLB

CONTACT

97235305992; Sue.Mayost@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Multiple Sclerosis Center

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 12, 2021
• Study Start: March 20, 2021
• Primary Completion: December 1, 2021
• Study Completion: September 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)