Immune Response to COVID-19 Vaccine in Multiple Sclerosis Patients Tre

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

Status unknownNot a drug-phase studyMS (type not specified)NCT05075499

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • COVID-19 vaccination

What it measured

Main measures

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

    6 months

Other measures (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

    Immune response

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

    12 months

    Thinking and memoryImmune response

  • 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

    Thinking and memoryImmune response

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

    12 months

    Thinking and memory

  • 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

    Thinking and memoryImmune response

  • 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

    Thinking and memoryImmune response

Who could take part

MS (type not specified) · 18 and over

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Mar 2021

    2. Main results due

      Dec 2021

    3. Finished

      Sept 2022

    Assembled by software from public sources.