Effect of Disease Modifying Therapy on Antibody Response to COVID19 Vaccination in Multiple Sclerosis

NCT04834401 | Completed

• 1 other identifier: US-TYS-11909
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Covid19

Keywords

mRNA vaccine; Ocrelizumab; Natalizumab; Dimethyl Fumarate; Diroximel Fumarate; Interferon Beta; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Geometric mean titers (GMT) of anti-SARS-CoV-2 spike IgG for each treatment at 8 weeks from initial vaccination dose

  Serum Sample

  8 weeks

Secondary Outcomes (4)

• Proportion of participants with >4 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks

  8 weeks

• Proportion of participants with >2 fold increase in anti-SARS-CoV-2 spike IgG between baseline and 8 weeks

  8 weeks

• Median time from peak to complete absence of anti-SARS-CoV-2 IgG for each treatment arm

  18 months

• Proportion of spike-specific T-cells/Total T cells

  36 Weeks

Other Outcomes (3)

• Proportion of participants with known vaccine-related side effects

  8 weeks

• COVID-19 Infections

  18 months

• Effect of Duration of DMT use on Humoral Response to mRNA-1273

  8 week

Study Arms (4)

Natalizumab

Natalizumab (minimum of 6 doses at standard interval)

Fumarates

Fumarates (dimethyl fumarate or diroximel fumarate)

Interferon Beta 1a

Interferon Beta 1a (or pegylated Interferon Beta-1a)

Ocrelizumab

Ocrelizumab (minimum of 2 full cycles of 600mg)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified from the MS Center utilizing the electronic medical record, clinic visits or telephone encounters related to COVID-19 vaccination and recruited consecutively. Patients who appear to meet eligibility criteria will be contacted by research staff and offered informed consent using the Multiple Sclerosis Comprehensive Care Center standard protocol. If possible the baseline serum sample will be collected at the initial research visit, following the informed consent process.

You may qualify if:

• 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)

You may not qualify if:

• 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:
• Participants will agree to five visits during the study and serum will be collected at the following time points:
• Baseline/Screening visit
• weeks after 1st dose/4 weeks after 2nd dose (+/- 1 week)
• weeks (+/- 2 weeks)
• weeks (+/- 4 weeks)

Sponsors & Collaborators

• St. Barnabas Medical Center: lead

Study Sites (1)

Saint Barnabas Medical Center

Livingston, New Jersey, 07039, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum will be stored for up to 2 years from enrollment

MeSH Terms

Conditions

Multiple Sclerosis; COVID-19

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

Study Officials

• Matthew A Tremblay, MD, PhD

  RWJBarnabas Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Multiple Sclerosis Research

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 8, 2021
• Study Start: March 22, 2021
• Primary Completion: May 17, 2022
• Study Completion: May 17, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

US (1)