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Clinical Trial: Effect of Disease Modifying Therapy on Antibody Response to COVID-19 Vaccination in People with MS

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Details
Type of MS: PPMS|PRMS|RRMS|SPMS
Treatment mode of action: To determine safety and effectivenesss
Number of Subjects: 120
Medication: Disease modifying therapy
Location: New Jersey
Institutions: Saint Barnabas Medical Center
200 South Orange Ave, Suite 124
Livingston, NJ 07039 Contact Information
Phoebe DelBoccio
973-322-7046
phoebe.delboccio@rwjbh.org

Funding:

Research support provided by Biogen

Description

The objective of the study is to determine whether certain disease modifying therapies impair or shorten immune responses to COVID-19 vaccines. The researchers are measuring antibody levels following vaccination with Moderna mRNA-1273 vaccine in people with MS. Therapies under study include Ocrelizumab (Tradename Ocrevus), Natalizumab (Tysabri), Dimethyl Fumarate (Tecfidera), Diroximel Fumarate (Vumerity), and Interferon Beta (Avonex, Rebif, Betaseron, or Plegridy).

If possible, a baseline visit should occur within 7 days of the first dose of vaccine. Otherwise, the first study visit can take place 8 weeks after the first dose of the Moderna vaccine.

Two tubes of the blood will be collected for antibody testing at each study visit on the following schedule: Baseline, 8 weeks, 24 weeks, 48 weeks, and 72 weeks.

Participants will be asked to provide details of their medical and treatment history, including approximate date of first multiple sclerosis symptoms, date of formal diagnosis, and dates of prior and current medications use.

articipants will be asked at 8 weeks to complete a questionnaire about vaccine side effects. Participants will be asked at each visit about COVID-19 exposure, symptoms, or diagnosis, as wellas any changes in medications or supplements.

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