Evaluating the Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in People With Multiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- St. Barnabas Medical Center
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This observational study is intended to evaluate the effect of disease modifying therapies on antibody responses to the mRNA-1273 vaccine (Moderna) for COVID-19. We hypothesize that the use of certain disease modifying therapies, particularly ocrelizumab, will mute and/or shorten the duration of humoral response to mRNA vaccines.
Detailed Description
COVID-19 is a potentially fatal respiratory illness, caused by the novel coronavirus, SARS-CoV-2, which developed into a pandemic claiming the lives of over 500,000 people in the United States and over 2.5 million worldwide. Antibodies against the spike glycoprotein are believed to confer immunity to SARS-CoV-2. Multiple sclerosis (MS) is an autoimmune disease of the central nervous system, which is typically treated with immunomodulating medications, referred to as disease modifying therapies (DMTs). Some DMTs resulted in a diminished capacity to develop antibodies against natural infection with SARS-CoV-2. This study is designed to evaluate and compare the effect of DMTs on antibody response to mRNA vaccines for COVID-19. Serum samples will be collected from 30 participants per treatment arm at 8 weeks, 24 weeks, 36 weeks, and 48 weeks, following vaccination with mRNA-1273. Geometric mean titers of anti-SARS-CoV-2 spike IgG will be measured to evaluate and compare peak antibody titers, as well as the duration of antibody response. The results will likely impact clinical decision-making, and guide treatment strategies for safely managing MS during the ongoing pandemic.
Investigators
Matthew A. Tremblay
Director of Multiple Sclerosis Research
St. Barnabas Medical Center
Eligibility Criteria
Inclusion Criteria
- •Men and women aged 18 to 65 years inclusive
- •Patients who have signed written informed consent.
- •Patients stable on current MS DMT for \>6 months including:
- •Natalizumab (received a minimum of 6 doses per USPI)
- •Fumarates (dimethyl fumarate or diroximel fumarate)
- •Interferon Beta 1a (or pegylated Interferon Beta-1a)
- •Ocrelizumab (received a minimum of 2 full cycles per USPI)
Exclusion Criteria
- •Known history of SARS-CoV-2 infection
- •Is pregnant or breastfeeding
- •≤6 months on current therapy (MS Participants)
- •Participation in another investigational study
- •Recent immunization with a non-COVID vaccine (within 4 weeks)
- •Known or suspected allergy or history of anaphylaxis or other significant adverse reaction to the COVID-19 vaccine or its excipients
- •Absolute lymphocyte count \<0.5 x 10\^9/L
- •Concurrent Intravenous or Subcutaneous Immunoglobulin treatment (IVIG/SCIG)
- •Received systemic corticosteroids \< 30 days prior to Vaccine Dose 1
- •Visit and Assessment Schedule:
Outcomes
Primary Outcomes
Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose
Time Frame: 8 weeks
Serum Sample
Secondary Outcomes
- Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks(8 weeks)
- Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks(8 weeks)
- Proportion of spike-specific T-cells/Total T cells(36 Weeks)
- Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm(18 months)